Clinical Digest: Recent Clinical Trials on Ebola Virus Disease
To assist researchers and healthcare practitioners in staying up-to-date with the latest advancements in clinical research, the Clinical Digest Team has compiled a comprehensive list of recent clinical trials related to Ebola Virus Disease. These trials are organized by their release dates for your convenience. (Last updated on: 2025-05-02)
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TABLE 1: Clinical Digest: Recent Clinical Trials on Ebola Virus Disease
| Clinical Trial | Contact(s) | Date | |
|---|---|---|---|
| 1 | Evaluation of The Efficacy of A Post-exposure Prophylaxis (PEP) Strategy in Contacts At High Risk of Developing Ebola Virus Disease (EVD) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms. The trial will be open during EVD epidemics and will recruit asymptomatic participants at high risk of developing EVD. Participants will be randomized (1:1) into one of two trial arms: * Arm 1 (ERV): Ervebo D0 (72 million PFU IM) * Arm 2 (ERV+IMZ): Ervebo D0 (72 million PFU IM) + Inmazeb IV (150 mg/kg) D0 + Ervebo D56 (revaccination) Definition of high-risk: Direct contact with a person with confirmed EVD presenting with diarrhoea, vomiting or externalized haemorrhages (wet symptoms), … |
ANRS EMERGING INFECTIOUS DISEASES | 2025-05-01 |
| 2 | An Open-Label, Case-Control Study to Compare The Anamnestic Response to The Recombinant Vesicular Stomatitis Delta Glycoprotein Zaire Ebola Virus (ZEBOV) Glycoprotein (rVSVDG-ZEBOV-GP) Ebola Virus Vaccine Among Ebola Virus Disease Survivors to The Primary Immune Response Among Naïve Age and Sex-Matched Controls PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a vaccine-related clinical trial which will be conducted by our study team at Kenema Government Hospital (KGH)’s Viral Hemorrhagic Fever Program in collaboration with Tulane University School of Medicine. This study is funded by Merck \& Co., … |
JOHN SCHIEFFELIN; | 2025-05-01 |
| 3 | Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with The Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC: A Mix-and-match Phase II RCT PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules. Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE’s) and grading physical and vital signs evaluations. |
WIM ADRIAENSEN; | 2025-02-25 |
| 4 | EbolaCov: A Phase IV, Single-centre, Single-blinded, Randomized Controlled Trial to Assess Safety and Immunogenicity of RVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrent With MRNA COVID-19 Vaccine Booster Doses in Healthy African Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Concurrent vaccination scheduling for key target populations in Rwanda, such as healthcare workers, may confer significant advantages in the provision of vaccine coverage to several infectious diseases. This is a phase IV vaccine trial that looks to establish if two licenced vaccines, the rVSVΔG-ZEBOV-GP vaccine for protection against Ebola virus and messenger ribonucleic acid (mRNA) COVID vaccine for protection against SARS-CoV-2 virus, given concurrently to self selected healthy adult volunteers confers an acceptable safety profile and immunogenicity response. |
CHRISTOPHER GREEN; | 2024-10-01 |
| 5 | Utilizing Traditional and Modern Music Performance in Eye Health Education to Improve Child Eye Health Service Uptake in Zanzibar PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: In Zanzibar, around 22,000 children (4% of those aged 6 to 12) need treatment for eye issues like conjunctivitis or require glasses. A 2017 study found that 42% of rural children needing glasses didn’t have them. Many locals distrust Western medicine and prefer traditional remedies, rejecting public health efforts such as posters and brochures. Globally, eye health promotion has been underfunded and overlooked. Research suggests community-designed interventions and behavior change studies are needed to promote sustainable eye health practices. Arts-based interventions using traditional storytelling and performances have been effective in Africa, … |
VING FAI CHAN; | 2024-01-15 |
| 6 | Proposal to Address The Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Mubende District in Central Uganda (Ebola+D Project) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Screen participants attending 11 healthcare facilities in Mubende District for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention [a stepped care collaborative delivery model to address the medium- to long-term EBOLA associated psychological Distress and psychosocial problems] . A cohort of Ebola Virus Disease (EVD) affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, … |
EUGENE KINYANDA; | 2023-09-22 |
| 7 | Community Preparedness for Outbreak Response and Readiness for ZEBOV Vaccination in Liberia PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This community-based mixed methods study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations, including acceptance for Ebola vaccines. |
STEPHEN B KENNEDY; | 2023-06-01 |
| 8 | Assessment Of Gene Expression Of Suppressor Of Cytokine 3, Interferons Alpha And Beta In Cutaneous Warts PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Warts are common epidermal growths caused by various strains of human papilloma virus (HPV). Viral warts are common with a prevalence rate of 7-12%. Human papilloma virus is small non enveloped viruses that contain a double-stranded DNA genome. There are more than 200 HPV genotypes are reported, however, the high-risk types, including HPV genotype-16 (HPV16), 18, 31, and 45, are the causes of 80% of cervical cancers. |
REHAM HELAL ABOELHAMD; | 2023-04-15 |
| 9 | Natural History, Disease Progression, and Long-Term Neurologic Sequelae of Ebola Virus Disease Survivors in PREVAIL III PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Ebola virus disease (EVD) is a viral fever that can cause internal bleeding. The death rate from EVD is very high. In a 2014 outbreak in West Africa, 28,000 were affected and 11,000 died. EVD may also affect the brain and nervous system, … |
BRIDGETTE J BILLIOUX; | 2023-02-21 |
| 10 | In Vivo Investigation on Mitochondrial Dysfunction in Post-COVID Fatigue and Cancer Fatigue PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To date, little is understood regarding post-COVID fatigue or cancer fatigue though it is known to affect a large proportion of patients (10-70% depending on the population). This study aims to investigate potential mitochondrial function and metabolic changes in brain to provide further information regarding the etiology of these changes leading to fatigue. This study hypothesized that Post-COVID fatigue is ensued by perturbations in metabolism and mitochondrial function in the brain. This is a case-control study. In this study, … |
JEONG HOON K LIM; | 2022-12-09 |
| 11 | A Phase 2, Open-label, Study to Evaluate The Safety and Immunogenicity of A Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV, MVA-BN-Filo in Adults and Children Originally Enrolled in The Control Arm of The EBOVAC-Salone Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study |
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE | 2022-09-19 |
| 12 | Psychologic Impact of COVID-19 Pandemic on The Hospital Staff of The Nouvelle Aquitaine Area : A Prospective Longitudinal Study By Self-administered Questionnaires PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: Evaluation of the psychological impact of the COVID-19 pandemic on hospital staff in the French Nouvelle Aquitaine area, through a longitudinal study with repeated self-administered psychologic scales |
CENTRE HOSPITALIER CHARLES PERRENS BORDEAUX | 2022-09-01 |
| 13 | Investigation of The Persistence of SARS-CoV-2 in The Olfactory Mucosa of Patients With Prolonged Symptoms of COVID-19 With Neurocognitive Complaints: A Prospective Cross-sectional Multicenter Case / Control Study (NEUROCOVID) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: NEUROCOVID is a prospective multicenter study comparing the proportion of patients with SARS-CoV-2 viral RNA at the level of the olfactory clefts in a group of cases compared to a group of controls as well as the correlations between the virological and cellular abnormalities observed in the olfactory mucosa and the severity of the clinical neurological profile |
MATHIEU VEYRAT; | 2022-07-01 |
| 14 | A Phase Ib Study to Determine The Safety and Immunogenicity of A Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in Tanzanian Healthy Adult Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial |
UNIVERSITY OF OXFORD | 2022-03-30 |
| 15 | Phase IIa Pilot Study Evaluating The Impact of Delay Between Administration of Inmazeb Administration and Vaccination By Ervebo on Vaccine Immune Response on Healthy Volunteers PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Ebola virus disease (EVD) is emerging regularly in various African countries for various reasons: during contact with mortal remains, during an unsafe burial or following the viral dissemination around a recovered patient. However, tools to fight the spread of the disease are being made available to countries affected by MVE. A vaccine (Ervebo), developed by the Merck laboratory, … |
DENIS MALVY; | 2022-03-01 |
| 16 | Investigation of The Effectiveness of Telerehabilitation in Individuals With Rotator Cuff Tear PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The majority of patients presenting with shoulder pain are those with rotator cuff problems. Although telerehabilitation is a promising field in many areas, there is still limited high-quality research with strong evidence of its effectiveness for musculoskeletal problems. In this study, online rehabilitation and face-to-face rehabilitation will be compared in people with partial rotator cuff tears. |
EMRAH ZIREK; | 2022-02-07 |
| 17 | Surveillance of RVSV-ZEBOV Vaccine-induced Immunity Against Ebola Virus in Previously Vaccinated Health Care Workers < EBOSURV > PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: During the previous Ebola virus disease (EVD) outbreaks, the institute National de Recherche Biomédicale (INRB) and other institutional’s staff in Democratic Republic of the Congo (DRC) got vaccinated with the rVSV-ZEBOV vaccine. However, the longevity of Ebola virus (EBOV)-specific immune responses after vaccination has not been studied extensively (only 1-2 years) nor comprehensively (only humoral), despite the wide use of this vaccine. With the re-emergence of Ebola in North-Kivu from a previously vaccinated individual, and the new planned vaccination campaign (considering homologous booster doses for previously vaccinated HCW) in light of the new outbreak in Beni, … |
INSTITUTE OF TROPICAL MEDICINE BELGIUM | 2021-12-13 |
| 18 | A Clinical Trial to Assess The Safety and Immunogenicity of LNP-nCOV SaRNA-02, A Self-amplifying Ribonucleic Acid (saRNA) Vaccine, in SARS-CoV-2 Seronegative and Seropositive Uganda Population PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: COVAC Uganda is a study that is looking at the use of an innovative self-amplifying RNA (saRNA) vaccine (LNP-nCOV saRNA-02) against the virus (SARS-CoV-2) that causes COVID-19 and assessing the immune response in SARS-CoV-2 antibody seronegative and seropositive individuals. saRNA is designed to amplify the quantity of RNA upon injection to produce further antigen, thereby enabling lower doses for administration. In the trial COVAC1, Imperial College London is currently evaluating one COVID-19 saRNA vaccine candidate in doses from 0.1-10ug for individuals who are seronegative for SARS-CoV-2 antibodies at baseline. Interim analyses of COVAC1 has shown a dose dependent response; however, … |
PONTIANO KALEEBU; | 2021-12-02 |
| 19 | Culturally Adapted Cognitive Behavioral Intervention to Reduce Psychological Distress Among COVID-19 Survivors: A Randomized Controlled Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The effectiveness study for Culturally-Adapted Cognitive Behavioral Intervention (CA-CBI) will be conducted with individuals infected with and recovered from Coronavirus disease (COVID-19) to measure if this intervention is effective in decreasing the COVID-19 survivors’ psychological distress. Potential participants will be given an informed consent and then, … |
KOÇ UNIVERSITY | 2021-11-17 |
| 20 | A Phase I Study to Determine The Safety and Immunogenicity of A Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in UK Healthy Adult Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: An open-label, non-randomised, dose escalation, first-in-human, single centre, phase I clinical trial to determine the safety and immunogenicity of a bivalent ChAdOx1 vectored vaccine against Zaire and Sudan Ebola virus species in healthy adult volunteers. |
PAOLA CICCONI; | 2021-11-11 |
| 21 | Phase IIa Pilot Study Evaluating The Efficacy of A Monoclonal Antibody and Vaccine-based Post-exposure Prophylaxis Strategy in High-risk Contact Cases of Ebola Virus Disease Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: – Three measures are currently being implemented to control Ebola outbreaks: – Monitoring of contacts – Isolation and treatment of sick people – Vaccination of the population in high-risk areas. – In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration. – Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD). – … |
ANRS EMERGING INFECTIOUS DISEASES | 2021-10-17 |
| 22 | An Open Label, Phase 2 Study to Evaluate The Safety and Immunogenicity of An Ad26.ZEBOV Booster Dose in Human Immunodeficiency Virus Positive (HIV+) Adults Previously Vaccinated With The Ad26.ZEBOV, MVA-BN-Filo Vaccine Regimen PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open label study to evaluate the safety and immune response to a booster dose of Ad26.ZEBOV Ebola vaccine in HIV+ adults from Kenya and Uganda. Only participants who have received the 2-dose Ebola vaccine regimen Ad26.ZEBOV/MVA-BN-Filo in the VAC52150EBL2002 vaccine trial about 4 years ago are eligible to take part. Approximately 50 healthy HIV+ adults, aged 18 – 50 years at the time of the parent trial, will be invited. Participants will first be asked to provide consent to participate in this study. Upon receiving the booster vaccination, … |
PONTIANO KALEEBU; | 2021-10-06 |
| 23 | A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate The Safety, Immunogenicity and Potential Efficacy of An RVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to An Approved COVID-19 Vaccine PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19. |
NEURORX | 2021-09-30 |
| 24 | Open-Label, Expanded Access Protocol of A Human Monoclonal Antibody, Ansuvimab (mAb114), Administered As An Investigational Therapeutic to Ebola-Infected Patients or As A High-Risk Ebola Post-Expo Related Papers Related Patents Related Grants Related Experts View Highlight: The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under expanded access. Ansuvimab is administered at 50 mg/kg as a single intravenous (IV) infusion |
JEAN JACQUES MUYEMBE-TAMFUM; | 2021-09-23 |
| 25 | Long-term Sequelae of COVID-19 (Myalgic Encephalomyelitis): An International Cross-Sectional Study PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The term recovery from COVID-19 caused by SARS-CoV-2 is unverified because the infection leaves many symptoms due to permanent effects on multiple organs; The primary objective of this research is to understand acute and chronic long COVID symptoms by asking questions detecting patient’s experience especially symptoms lasting for several months which is known as chronic fatigue syndrome(Myalgic encephalitis). The study focuses on symptoms describing Myalgic encephalitis which may still affect COVID patients for several months after the infection along with making a big picture about rare symptoms that may the patient experienced during or after the infection. A secondary objective of this research is to focus on the long-term sequelae effects and comorbidities following COVID-19 vaccination. |
ALEXANDRIA UNIVERSITY | 2021-09-01 |
| 26 | Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for The Treatment of Lassa Fever: A Randomized Controlled Open Label Phase II Clinical Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This exploratory, prospective, controlled, multisite, open label, randomized clinical trial with two treatment arms aims to compare favipiravir, a new treatment candidate for Lassa fever (LF), with the current standard of care, ribavirin. The primary endpoints of this research are (1) the description of classical pharmacokinetic parameters of favipiravir in comparison with ribavirin standard treatment in patients suffering from LF and (2) the safety and tolerability of both study drugs in the investigated regimens. |
PETER AKHIDENO; | 2021-07-30 |
| 27 | PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION: An Observational Quality Control Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Transmission of SARS-CoV-2 occurs through common routes, aerosols and medical procedure. Personal protective equipment (PPE) reduces the risk of contamination. The risk of contamination of skin and clothing may be particularly high during removal PPE. The Ministry of Health (MOH) of Israel adapted the technique of using a supervisor that monitors during removal of the PPE. The aim of this study to examine the using the pre-established protocol, … |
LUIS GAITINI; | 2021-07-15 |
| 28 | An Open Label Study to Evaluate The Safety and Immunogenicity of An Ad26.ZEBOV Booster Dose in Children Previously Vaccinated With The Ad26.ZEBOV and MVA-BN-Filo Vaccine Regimen PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later. |
DEBORAH WATSON-JONES; | 2021-07-08 |
| 29 | Effectiveness of Quercetin In The Treatment of SARS-COV 2 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name vitamin P because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins. Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America. Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, … |
RIADH BOUKEF; | 2021-06-01 |
| 30 | Africa COVID-19 Vaccine Hesitancy: A Multi-country Cross-sectional Study PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Vaccine hesitancy is defined by the WHO’s Strategic Advisory Group of Experts on Immunization as a ‘delay in acceptance or refusal of vaccination despite availability of vaccination services’. This varies in form and intensity based on when and where it occurs and what vaccine is involved. Several prophylactic vaccines against COVID-19 are currently available. As the world is beginning the roll-out the first approved vaccines, … |
DANIELA FUSCO; | 2021-05-05 |
| 31 | A Phase 1/2, Randomized, Controlled Open-label Trial to Evaluate The Safety and Immunogenicity of The RVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Healthy Children Aged 1 to 12 Years and in Their Adults And/or Children Relatives Living in Lambaréné, Gabon PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector. The study will enroll children of two age groups living in Lambaréné, … |
SELIDJI TODAGBE TODAGBE AGNANDJI; | 2021-04-09 |
| 32 | A Phase 2 Randomized, Double-blinded Trial to Evaluate The Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease. |
ANDREW EISENBERGER; | 2021-03-12 |
| 33 | Socio-psychological Status of Healthcare Workers During SARS-CoV2 Pandemic PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination. |
HAKAN GOKALP TAS; | 2021-03-01 |
| 34 | Randomized Controlled Clinical Study (RCT) Phase 3 of The Safety and Efficacy of Hypochlorous Acid in The Prophylaxis of Healthcare Personnel at High Risk of Infection By SARS-CoV2 (COVID19) Versus Placebo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level. In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, … |
JUAN ZAMBRANO; | 2021-02-15 |
| 35 | An Open Study of The Safety and Pharmacokinetics of A Drug for The Emergency Prevention of Ebola Virus Disease Based on Humanized Monoclonal Antibodies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Open-label safety, tolerability, pharmacokinetics and immunogenicity study in three dose escalation groups |
TATIANA ZUBKOVA; | 2021-02-15 |
| 36 | The Role of Virtual Peer Support Platforms for Reducing Stress and Burnout Among Frontline Healthcare Workers During COVID-19: A Randomized Controlled Trial PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Physician burnout has a significant impact on the wellness and productivity of physicians as well as patient health outcomes. Managing burnout among frontline workers is critical to Canada’s response to the COVID-19 pandemic, in order to support frontline workers and reduce inefficiencies and medical errors frequently linked to burnout, ultimately improving our ability to detect, treat and manage COVID-19 cases. Therefore, … |
ZAINAB SAMAAN (ZENA); | 2021-01-15 |
| 37 | Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015. It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method. In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method. Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks. |
MANFRED WEIDMANN; | 2021-01-15 |
| 38 | Phase 1b Trial to Evaluate Safety, Tolerability and Immune Responses of 2 Monovalent Chimpanzee Adenoviral Vectored Filovirus (Ebola-S and Marburg) Vaccines to Healthy Adults, Collection of Plasma/Serum for The Purposes of Assay Development PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: • To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults. Secondary Objectives: – To evaluate the antibody response to Monovalent Chimpanzee Adenoviral Vectored Filovirus Ebola-S (cAd3-EBO-S) and Monovalent Chimpanzee Adenoviral Vectored Filovirus (Marburg) (cAd3 Marburg) vaccines as assessed by antigen glycoprotein (GP) specific (enzyme-linked immunosorbent assay) ELISA – To collect sufficient post-vaccination plasma to support further development of filovirus assays |
MICHAEL STEVENSON; | 2021-01-06 |
| 39 | Clinical Trial of Convalescent Plasma Administration As Adjunct Therapy for COVID-19 (Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan COVID-19) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Convalescent plasma (CP) has been the subject of increasing expectation for treating coronavirus disease 2019 (COVID-19). Reports on CP transfusion have shown promising clinical improvements without serious adverse events. To date, most studies focused on reporting CP treatment in patients with severe COVID-19, but only a few addressed benefits on less severe disease. The vast majority of studies reporting COVID-19 infection and treatment have come from earlier affected countries with established health systems and research infrastructure, while very few are from low- and middle-income countries (LMICs). Nonetheless, … |
DAVID H MULJONO; | 2020-12-01 |
| 40 | VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19. |
VA OFFICE OF RESEARCH AND DEVELOPMENT | 2020-11-16 |
| 41 | The COVID-19 and Healthcare Workers: An Active Intervention PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The overarching goal of this study is to examine the efficacy of a brief video intervention in reducing stigma and fear, and improving help-seeking behavior, among health care providers (N=1,200), with pre- post- and follow-up assessments (at day 14 and day 30). Participants will be recruited via Amazon Turk and randomly assigned to either a) a video-based intervention (day 1 and a booster intervention of the same content on day 14 of the study) featuring the personal story of a health care provider during COVID-19 pandemic, his/her struggles and barriers to care, (b) video-based intervention (day 1 only), … |
YUVAL Y NERIA; | 2020-10-21 |
| 42 | A Phase III Prospective, Interventional, Cohort, Superiority Study to Evaluate The Benefit of Rapid COVID-19 Genomic Sequencing (the COVID-19 GENOMICS UK Project) on Infection Control in Preventing The Spread of The Virus in United Kingdom NHS Hospitals PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, … |
JUDITH BREUER; | 2020-10-15 |
| 43 | A Phase 3 Open-label Randomized Clinical Trial to Evaluate The Safety, Reactogenicity and Immunogenicity of A 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed By MVA-BN-Filo in Healthy Pregnant Women PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2- dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \[Group A\]) and in control women (unvaccinated pregnant women \[Group B\]); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \[Group A\]) and in neonates/infants born to control women (unvaccinated during pregnancy \[Group B\]). |
JANSSEN VACCINES & PREVENTION B V | 2020-10-05 |
| 44 | Intravenous Immunoglobulins for The Treatment of Covid-19 Patients: A Clinical Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime. We would be able to generate the concentrated antibodies specific against coronavirus (Covid-19). These antibodies can be used as serum therapy. Aside from a Covid-19 vaccine, antibodies from recovered patients could provide a short-term passive immunization to the disease. Those antibodies can be extracted from the blood serum of surviving patients and then injected into infected people. Passive immunization usually lasts for a few weeks or months, after which those borrowed or donated antibodies, … |
FRIDOON JAWAD AHMAD; | 2020-09-15 |
| 45 | Diagnostic Accuracy of COVID-19 Detection Tests in Different Body Fluids of Infected Men and Concordance With Viral Cultures PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A clinical and experimental study will be carried out in which the clinician will investigate the PCR of the virus early in different body fluids (blood, semen, urine, saliva) and monitor its experimental clearance and evaluate in vitro diagnostic tests and inhibitory factors of viral proliferation. |
RICARDO REGES MAIA DE OLIVEIRA; | 2020-09-01 |
| 46 | Effectiveness of The Use of Personal Protective Equipment in Addition to Tenofovir/Emtricitabine for The Prevention of The Transmission of SARS-COV-2 to Health Care Personnel. Randomized Clinical Trial PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A Randomized Clinical Trial. This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers. The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, … |
SANDRA LILIANA VALDERRAMA; | 2020-08-30 |
| 47 | The C3 Nitazoxanide for Mild to Moderate COVID-19 in HIV-infected and HIV-uninfected Adults With Enhanced Risk: A Double-blind, Randomised, Placebo-controlled Trial in A Resource-poor Setting PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: COVID-19 due to SARS-CoV-2 infection is a rapidly escalating global pandemic for which there is no proven effective treatment. COVID-19 is multi-dimensional disease caused by viral cytopathic effects and host-mediated immunopathology. Therapeutic approaches should logically be based on interventions that have direct anti-viral effects and favourably modulate the host immune response. Thus, an optimal drug regimen in ambulatory patients should collectively (i) target and reduce viral replication, (ii) upregulate host innate immune anti-viral responses, (iii) have favourable immunomodulatory properties, … |
KEERTAN DHEDA; | 2020-08-27 |
| 48 | Pilot Clinical, Statistical and Epidemiological Study on Efficacy and Safety of Convalescent Plasma for The Management of Patients With COVID-19 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission. SARS-CoV-2, and its predecessor SARS-CoV-1, … |
UNIVERSIDAD AUTONOMA DE COAHUILA | 2020-07-06 |
| 49 | DEFINE – Evaluating Therapies for COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, … |
KEV DHALIWAL; | 2020-07-03 |
| 50 | Epidemiology and Clinical Characteristics of Emerging and Re-emerging Infectious Diseases PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective observational study to include participants with a spectrum of emerging or unknown pathogens with the objective to determine etiology and clinical characteristics of those diseases. |
SOUNKALO DAO; | 2020-06-18 |
| 51 | Antibody Responses in Asymptomatic Close Contacts of COVID-19 Patients and Their Implications PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: After several cases of pneumonia with an unfamiliar etiology were observed at the end of 2019, the National Health Commission of China released more details about the epidemic in early 2020. The pathogen was identified as a novel coronavirus and named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as it has a phylogenetic similarity to SARS-CoV. Since then, SARS-CoV-2 has spread rapidly and the resulting coronavirus disease 2019 (COVID-19) has been declared a public health emergency of international concern (PHEIC) by the World Health Organization (WHO). SARS-CoV-2 is highly contagious, … |
ALIAE AR MOHAMED HUSSEIN; | 2020-06-15 |
| 52 | Randomized Double-Blind Placebo-Controlled Trial on The Safety and Efficacy of Imatinib for Hospitalized Adults With COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19 |
ASHKAN EMADI; | 2020-06-02 |
| 53 | Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The discovery of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the outbreak of coronavirus disease 2019 (COVID-19) are causing public health emergencies. A handful pieces of literature have summarized its clinical and radiologic features, whereas therapies for COVID-19 are rather limited. To evaluate the efficacy of convalescent plasma therapy in COVID-19 patients. |
OSSAMA HAMDY SALMAN; | 2020-05-29 |
| 54 | Convalescent Plasma Transfusion Therapy in Severe COVID-19 Patients- A Tolerability, Efficacy and Dose-response Phase II RCT PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: As of March 18, 2020, COVID-19 cases were reported in approximately 195 countries. No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, such as remdesivir and favipiravir, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma (CP) was recommended as an empirical treatment during outbreaks of Ebola virus in 2014. A protocol for treatment of Middle East respiratory syndrome coronavirus (MERS-CoV) with CP was established in 2015. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza, … |
FAZLE RABBI CHOWDHURY; | 2020-05-20 |
| 55 | DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, … |
LUIS VILLELA; | 2020-05-20 |
| 56 | Statin Therapy and COVID-19 Infection (STACOV PROJECT) PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Considering that simvastatin, and probably statins in general, interfere with SARS-cov-2 cellular uptake and some inflammatory pathways activated by the virus, those patients on statin therapy should be less vulnerable to infection and their clinical course and prognosis should be better than that in individuals not on statin therapy. |
LUIS MASANA; | 2020-05-14 |
| 57 | Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection Related Papers Related Patents Related Grants Related Experts View Highlight: The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP during a viral pandemic must consider the supply of the product, ideal patient selection, and appropriate timing in order to produce maximum benefit with a scarce resource [2]. Currently, the FDA suggested guidelines for use include severe, critical or at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2 antibodies is theoretically early in the course of the illness [1], before multiorgan failure or a maladaptive immune response, … |
LARKIN COMMUNITY HOSPITAL | 2020-05-12 |
| 58 | Efficacy and Safety of Convalescent Plasma Vs Human Immunoglobulin for The Treatment of COVID-19 Pneumonia: A Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, … |
CENTENARIO HOSPITAL MIGUEL HIDALGO | 2020-05-06 |
| 59 | A Phase 2 Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Purpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19. |
THOMAS E. COYLE; | 2020-05-05 |
| 60 | Efficacy and Safety of High-Titer Anti-SARS-CoV-2 (COVID19) Convalescent Plasma for Hospitalized Patients With Infection Due to COVID-19 to Decrease Complications: A Phase II Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review. |
JEFFREY STUREK; | 2020-05-05 |
| 61 | Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020 PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Experimental Use of Convalescent Plasma of Passive Immunisation In Current COVID-19 Pandemic in Pakistan in 2020 Rationale & Objective: This study would help to gather real-life setting clinical data in local population, ultimately leading to increased evidence based management of the disease condition in the said population. Eligibility: 1. informed consent must have been obtained 2. confirmed COVID-19 cases confirmed by RT-PCR laboratory tests 3. moderately severe or severe life-threatening COVID-19 related features: a) Moderately Severe disease as defined by the following features: i) Shortness of breath, ii) respiratory rate ≥ 30/min, iii) arterial blood oxygen saturation ≤ 92%, … |
TAHIR SHAMSI; | 2020-05-01 |
| 62 | Efficacy and Safety of Hyperimmune Plasma Treatment in Patients With COVID-19 Severe Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Passive immunotherapy through plasma infusion of convalescent subjects – convalescent plasma – or hyperimmune plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, … |
LUCA GALLELLI; | 2020-05-01 |
| 63 | Convalescent Plasma for Passive Immunization in COVID-19 ICU Patients: An Interventional Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms |
M.IRFAN MALIK; | 2020-05-01 |
| 64 | Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world. To limit the influx of patients and avoid overstretching Health systems, … |
JEAN-PHILIPPE LANOIX; | 2020-04-29 |
| 65 | A Phase 2, Multi-Center, Randomized Clinical Trial to Evaluate The Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma). |
MAX O’DONNELL; | 2020-04-21 |
| 66 | Strain Study: To Access The Egyptian COVID-19 Whole Genome (Dominant Strain) By Next Generation Sequencing (NGS) and Compare to The International Worldwide Database PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an exploratory study that will be performed on confirmed positive COVID-19 samples to identify the dominant viral genome strain in Egyptians using next generation sequencing (NGS). |
HESHAM ELGHAZALY; | 2020-04-20 |
| 67 | Efficacy and Safety of Favipiravir Compared to The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal. |
SEYED SINA NAGHIBI IRVANI; | 2020-04-20 |
| 68 | Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: A Prospective Randomized Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication.; therefore, … |
MANAF AL QAHTANI; | 2020-04-19 |
| 69 | A National Collaborative Multicenter Phase II Study for Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19 PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Coronavirus disease (COVID-19) pandemic has started to affect Saudi Arabia and is expected to cause a lot of morbidities and many patients, especially the elderly, will require intensive care unit (ICU) support to survive as its lethality increases with the increasing age. Development of a vaccine by pharmaceutical companies like Roche and antibody concentrates from convalescent patients’ plasma by Takeda will take 10-12 months to complete, … |
HANI AL-HASHMI; | 2020-04-18 |
| 70 | Evaluation and Support to Ebola Virus Disease Cured Patients and Their Contacts in The Democratic Republic of The Congo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Ebola virus is one of the most dangerous human pathogens and is an emerging public health problem in sub-Saharan Africa. Ebola virus disease (EVD) first appeared in 1976. The current epidemic in the Democratic Republic of the Congo (DRC) is one of the largest and most complex ever recorded, and is not yet under control: a new death has been reported on April 10th, 2020. The epidemic was declared a public health emergency of international scope by the World Health Organization (WHO) on July 17th, … |
INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE FRANCE | 2020-04-16 |
| 71 | Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, … |
BRIAN PEPPERS; | 2020-04-16 |
| 72 | Understanding Immunology and Patient Outcomes of COVID-19: A 1-Year Longitudinal Follow-up Study of Hospitalized Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The novel SARS-CoV-2 virus has quickly spread worldwide, with substantial morbidity and mortality. There is very limited understanding of the short- and longer-term inflammatory/immunological and clinical course. However, the investigators expect survivors from severe COVID-19 to experience persistent functional impairments, as demonstrated in prior studies of patients with acute respiratory distress syndrome (ARDS) and other acute viral illnesses. Notably, however, few studies have ever investigated the biologic mechanisms underlying these functional impairments. Understanding these features of COVID-19 will improve the ability to design acute therapies and recovery-focused interventions. To address these knowledge gaps, the investigators propose a two-center, … |
RENEE STAPLETON; | 2020-04-16 |
| 73 | A Study of Mesenchymal Stem Cells As A Treatment in Patients With Acute Respiratory Distress Syndrome Caused By COVID-19 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment. |
JESUS PEREZ; | 2020-04-16 |
| 74 | Collection of COVID-19 Convalescent Plasma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Patients who are severely ill with COVID-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. Efforts to initiate the collection and infusion of these products to high risk patients have been initiated around the world and the FDA has recently provided information about how this could be accomplished. As the Jefferson Blood Donor Center already has processes to collect, test and process blood, … |
THOMAS JEFFERSON UNIVERSITY | 2020-04-13 |
| 75 | Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a standardized protocol for the rapid, coordinated clinical investigation of severe or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19) will be enrolled. This protocol has been designed to enable data and biological samples to be prospectively collected and shared rapidly in a globally-harmonized sampling schedule. Multiple independent studies can be easily aggregated, … |
LAUREN SAUER; | 2020-04-09 |
| 76 | Assessment of The Psycho-social Impact of COVID-19 Outbreak (COM-COVID) PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Added to this, the social ecosystem and family finances are also severely affected. After several months of the outbreak start and several weeks of quarantine and self-isolation, the emotional burden on the community has increased. Added to this, many of the confirmed cases are healthcare workers. In addition to the risk of infection, … |
CRIS VILAPLANA; | 2020-03-31 |
| 77 | Open-label Phase 2 Study to Evaluate The Immunogenicity and Safety of A Prophylactic Vaccination of Health Care Providers By Administration of A Heterologous Vaccine Regimen Against Ebola in The Democratic Republic of The Congo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, … |
PIERRE VAN DAMME; | 2019-12-18 |
| 78 | Evaluation of A Heterologous, Two-dose Preventive Ebola Vaccine for Effectiveness and Safety in The Democratic Republic of The Congo PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: A single arm, open-label, non-randomized, interventional phase 3 study to measure safety and effectiveness of a heterologous, two dose preventative vaccine (Ad26. ZEBOV, MVA-BN®-Filo) against Ebola Virus Disease. |
JEAN-JACQUES MUYEMBE-TAMFUM; | 2019-11-14 |
| 79 | Piloting Clinical Bacteriology in The Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Despite access to experimental Ebola Virus Disease (EVD)-specific treatments, about 30% of patients still die in the Ebola Treatment Centers (ETC) in DRC. There is limited study done about the potential contribution of bacterial co-infections (in particular bloodstream infections) to this adverse outcome, as blood cultures were so far rarely available in epidemic areas. Findings from patients treated in Europe and the USA, and case discussions in the field call for further investigation. Building further on an ongoing microbiological surveillance project of ITM and INRB in DRC, … |
OCTAVIA LUNGUYA; | 2019-11-11 |
| 80 | Prevention of Invasive Group B Streptococcus Disease in Young Infants: A Pathway for The Evaluation & Licensure of An Investigational Maternal GBS Vaccine (Work Package 2) PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations associated with research in this population. The goal of maternal immunisation is to boost maternal levels of specific antibodies to provide the newborn and young infant with sufficient immunity at birth, through trans placental transfer in-utero, … |
KIRSTY LE DOARE; | 2019-10-01 |
| 81 | PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: There are many people living with human immunodeficiency virus (HIV) infection in Liberia. Most experts consider HIV an epidemic there. Researchers want to collect health data from Liberians with HIV over several years. This may help HIV prevention and treatment programs in Liberia. Objective: To learn more about how HIV affects people in Liberia. Eligibility: People with HIV in Liberia Design: Participants will be screened with a blood sample. Participants will visit the study clinic about 10 times over 3 years. They will need to return to the clinic after some visits to get test results. The visits will be closer together during the first part of the study and less frequent later. At each study visit, participants will: * Have a brief physical exam * Answer questions about how they are feeling and what medicines they are taking * Have blood taken from an arm vein by a needle * Give urine samples Participants ages 12 years or older may be asked questions about HIV risk behaviors. These include sex practices and drug use. Participants ages 18 years or older may be asked how their HIV infection makes them feel emotionally. Participants may be asked to join a research substudy. This will be about tuberculosis (TB) testing in people with HIV. For this substudy, participants will have a TB skin test. A small amount of liquid will be injected under the skin on the arm. Participants will return to the clinic a few days later. The test area will be checked. They will get their test results. |
STEPHEN A MIGUELES; | 2019-08-22 |
| 82 | An Open-label, Single Arm Study to Provide Additional Information on Immunogenicity and Safety of Ad26.ZEBOV/MVA-BN-Filo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: An open-label, single arm phase II study of the candidate Ebola Vaccine Ad26.ZEBOV/MVA-BN®-Filo |
MRC/UVRI AND LSHTM UGANDA RESEARCH UNIT | 2019-08-01 |
| 83 | A Cohort Study to Evaluate The Long-term Safety and Immunogenicity of The Candidate Ebola Vaccines Ad26.ZEBOV and MVA-BN®-Filo in Adults and Children PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study evaluating the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in participants who were exposed to these vaccines in the VAC52150EBL3001 trial (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494). No investigational vaccine will be administered during this study. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit. |
DEBORAH WATSON-JONES; | 2019-07-22 |
| 84 | A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate The Safety, Tolerability and Immunogenicity of Two Doses of An Ebola Sudan Chimpanzee Adenovirus Vector Vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola vaccine in healthy adults. VRC-EBOADC086-00-VP, a chimpanzee adenovirus serotype 3 vector-based Ebola vaccine, encodes wild type (WT) glycoprotein (GP) from the Sudan strain of Ebolavirus and is administered intramuscularly (IM). |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2019-07-02 |
| 85 | A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for The Treatment of Patients With Ebola Virus Disease PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers. Objective: To study the safety and effectiveness of 4 drugs for people with Ebola virus. Eligibility: People of any age with Ebola infection who are in treatment centers Design: Participants will be screened with questions, … |
RICHARD T DAVEY; | 2018-11-21 |
| 86 | A Systems Biology Phase 1 Evaluation of The Safety, Reactogenicity, and Immunogenicity of Chimpanzee Adenovirus Type 3- Vectored Zaire Ebolavirus (ChAd3-EBO-Z) and Modified Vaccinia Ankara- Vectored Multivalent Filovirus (MVA-BN(R)-Filo) Vaccine Candidates PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults. |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2018-11-12 |
| 87 | Observational Study of The Clinico-biological Evolution and Standard of Care Offered to Patients With Ebola Virus Disease PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study highlighted the possibility, even in epidemic settings, of providing advanced supportive care for patients with VMEs. Indeed, while the prospect of offering any invasive medical care was widely discussed in 2014 in West Africa with the aim of limiting the exposure of caregivers, the epidemic of 2018-2019 has on the contrary seen the development of a number of medical care strategies, in parallel with the deployment of specific treatments. This study aims to describe a cohort of patients receiving this upgraded supportive care during the tenth epidemic in the DRC. |
ALLIANCE FOR INTERNATIONAL MEDICAL ACTION | 2018-08-01 |
| 88 | Expanded Access Protocol for Emergency Use of REGN3470-3471-3479 for The Treatment of Ebola Virus Disease Related Papers Related Patents Related Grants Related Experts View Highlight: Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD). |
REGENERON PHARMACEUTICALS | 2018-06-22 |
| 89 | An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of RVSVΔG-ZEBOV-GP PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease. |
EPICENTRE | 2018-05-28 |
| 90 | Behavior Change and Digital Health Interventions for Improved TB Treatment Outcomes: A RCT PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: Each year, 10.4 million patients are diagnosed with and 1.7 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18 month treatment regimen is often thwarted as patients fail to comply due to a lack of knowledge about the disease, desire for privacy, and/or stigma avoidance. Successful TB treatment is critical for reducing transmission, the selection of drug-resistant strains and treatment costs. Mobile health interventions promise to increase treatment success, … |
MASSACHUSETTS INSTITUTE OF TECHNOLOGY | 2018-04-13 |
| 91 | An Open, Dose Escalation Safety and Pharmacokinetics Study of The Medicine for Ebola Fever Emergency Prevention Based on Monoclonal Recombinant Antibodies With A Single Application in 3 Groups of Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase I clinical trial was developed to study drug safety, tolerability, and pharmacokinetics of the medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in single use in healthy volunteers with a dose escalation. A consecutive recruitment of people who signed the Informed Consent Form into three groups of volunteers with different drug doses is made according to the volunteers’ screening results. The total number of volunteers receiving the drug will be not less then 25 people.The purpose of this study is to assess safety, tolerability, … |
DMITRY LYOZNOV; | 2018-03-12 |
| 92 | Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects. Researchers want to learn what ill health conditions Ebola survivors have. They want to learn if Ebola survivors can infect others in their household through close contact. They also want to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they want to follow people in Liberia for 5 years. Objectives: – To learn how Ebola affects the health of survivors and the people they live with. Eligibility: – … |
MICHAEL C SNELLER; | 2017-12-02 |
| 93 | A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product GamEvac-Lyo, Vector-Based Vaccine Against Ebola Virus Disease, Lyophilisate for Preparation of Solution for Intramuscular Injection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease |
TATIANA ZUBKOVA; | 2017-11-03 |
| 94 | PREVAIL VII: Persistence of Ebola Virus in Ocular Tissues and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in over 11,000 deaths and disabling sequelae among survivors, among which eye complications are highly represented. Chronic intraocular inflammation and viral persistence may result in posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring surgical intervention to resolve. Approximately one out of ten Ebola survivors present with cataract, most of whom will require intraocular surgery during their lifetime, … |
NATIONAL EYE INSTITUTE NEI | 2017-09-21 |
| 95 | PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Genes are instructions that tell the body how to work and grow. They can affect how the body responds to infection. Researchers want to learn more about genes that affect how the body responds to the Ebola virus. Some people with Ebola get very sick and die. Others do not. The research may lead to better treatments for Ebola virus and other germs. Objective: To look for genes that may be related to a person s chance of getting very sick after coming in contact with the Ebola virus. Eligibility: People at least 3 years of age who either: Had Ebola Had close contact with someone who had Ebola Were in an Ebola vaccine study Design: Participants will have a small amount of blood taken from an arm vein by a needle. Researchers will collect participants data from other vaccine studies they may have been in. Participants may be asked questions about their health and social history. Some participants will have their blood tested for the infection syphilis and HIV, the virus that causes AIDS. Participants will be told the results and will get help finding care, if necessary. Some participants will have their blood sample tested to see if they have had Ebola in the past. Blood samples will be stored for future research. They will be marked with a code but not with participants names. |
LISA HENSLEY; | 2017-09-04 |
| 96 | 01 – GamEvac-Combi-2016 International Multicenter Study of The Immunogenicity of Medicinal Product GamEvac-Combi – Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 Ml+0.5 Ml/Dose PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety of medicinal product GamEvac-Combi – Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose |
SYLLA ALI LATHYR; | 2017-08-03 |
| 97 | A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate The Safety and Immunogenicity of The V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, placebo-controlled, multi-site, double-blind trial of V920 (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be conducted in conformance with Good Clinical Practices. The study will take place at 2 Canadian sites (Centre Hospitalier de l’Université de Montréal and Ottawa General Hospital) and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including screening. |
SCOTT HALPERIN; | 2017-08-01 |
| 98 | Evaluating The Long Term Immunogenicity of Ebola Virus Vaccines Ad26-ZEBOV, MVA-BN-Filo and RVSV-ZEBOV PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to investigate the persistence of the vaccine induced immune response between 24 – 60 months following primary vaccination. The study consists of three cohorts: Cohort 1: volunteers from the Phase 1 study of the various prime/boost regimes with two viral vectored Ebola vaccines: Ad26-ZEBOV and MVA-BN-Filo vaccines Cohort 2: volunteers who have been vaccinated previously with Ebola vaccine r-VSV-ZEBOV Cohort 3: volunteers from the Phase 2 study of 3 prime/boost regimes with Ad26.ZEBOV and MVA-BN-Filo vaccines (VAC52150EBL2001: EVOLVE). |
MATTHEW SNAPE; | 2017-05-17 |
| 99 | Partnership for Research on Ebola VACcinations (PREVAC) PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo. |
YAZDAN YAZDANPANNAH; | 2017-03-27 |
| 100 | Using Systems Vaccinology to Elucidate The Effects of Anti-inflammatory Therapy on Immune Response After Vaccination With A Live Attenuated Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Since the 1st pandemic of the 21st century caused by SARS coronavirus, the world has experienced outbreaks of swine origin H1N1 influenza, Ebola and Zika viruses, which have all resulted in global health crises. Rapid mass vaccination with an effective vaccine such as a live attenuated vaccine, of vulnerable immune-naïve populations to establish herd immunity is an approach to control outbreaks. Such live attenuated vaccine had been used with great success in sporadic yellow fever outbreaks and recently successfully employed in Ebola field trial, both of these diseases have the potential for pandemic spread. Indeed, … |
JENNY DR LOW; | 2017-03-08 |
| 101 | The First in The World Human Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The threat of MRSA and multi-drug resistant pathogens have been growing in recent years. A new means of countering the infectious threat is required and one such modality is the use of UV light for disinfection. The aim of the study is to proof the efficacy of the 222nm UV light in disinfection on patients with sacral sores. This is a first in human proof-of-concept study |
NATIONAL UNIVERSITY HOSPITAL SINGAPORE | 2016-12-01 |
| 102 | Using MHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers in Uganda PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study compares the traditional, didactic method of training Ugandan community health workers with training using tablets in pneumonia management, a common, life-threatening illness in children in rural areas. |
EDWARD J O’NEIL JR; | 2016-11-01 |
| 103 | A Phase IIa Safety Study to Assess The Safety and Immunogenicity of A New Leishmania Vaccine Candidate ChAd63-KH PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL). This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral and cellular immune responses generated by the candidate vaccine in patients, and observe any clinical changes in the disease over a 42 day period following vaccination. Study design: Eight adult volunteers will receive 1×10(10)vp and the subsequent eight volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1×10(10)vp or 7.5 x10(10)vp, … |
PAUL KAYE; | 2016-11-01 |
| 104 | Long-term Immune Durability After Vaccination With The Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine (VSV-EBOV): A Prospective Observational Cohort Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This prospective observational cohort study will follow the roughly 100 adults who received the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in order to determine their long-term (5-year) immune response to vaccination. |
SIEGRIST CLAIRE-ANNE; | 2016-11-01 |
| 105 | A Multicenter Study of The Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSVdeltaG-ZEBOV GP) for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebola Virus Exposure (PREPARE) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is also no vaccine to prevent infection either before or after exposure. Researchers want to test an Ebola vaccine. They want to give it to people before they are exposed to the virus in order to prevent the disease. Objectives: To see how long-lasting and effective the vaccine rVSV\[delta\]G -ZEBOV-GP (V920) is at preventing Ebola. Eligibility: Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical contact. Design: Participants will be screened with medical history, physical exam, and blood tests. Participants will get the study vaccine. It will be injected into their upper arm. Participants will be monitored closely for at least 30 minutes. They will get a diary card to record any symptoms they have from the vaccine for up to 14 days. Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36 months. Eighteen months after they join the study, participants will be randomly assigned to one of two groups. One group will get a second (or booster ) dose of the vaccine. The other group will not get a second dose. This study lasts 36 months. In December 2024, the study was approved to re-enroll up to 30 participants from the primary cohort to check longer-term immune response to the study vaccine beyond 36 months. |
RICHARD T DAVEY; | 2016-10-14 |
| 106 | Open Study of The Duration of Immunity After Vaccination With Medicinal Product GamEvac-Vector-Based Vaccine Against Ebola Virus Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvacVector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses. |
KONSTANTIN ZHDANOV; | 2016-10-01 |
| 107 | Open Study of The Duration of Immunity After Vaccination With Medicinal Product GamEvac-Combi – Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 Ml+0.5 Ml/Dose PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvac-Combi – Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses. |
KONSTANTIN ZHDANOV; | 2016-10-01 |
| 108 | PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess The Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, … |
ELIZABETH S HIGGS; | 2016-07-01 |
| 109 | A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to The Candidate Ebola Vaccines Ad26.ZEBOV And/or MVA-BN-Filo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies. |
JANSSEN VACCINES & PREVENTION B V | 2016-05-31 |
| 110 | Tolerance and Activity Assessment of High Doses of Favipiravir in Male Survivors With Ebola Virus in The Semen Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3 cohorts of 6 patients, each dose level including 2 sentinel patients. |
DAOUDA SISSOKO; | 2016-04-01 |
| 111 | Delivering Community-based Interventions and Disease Management Tools Across A Digital Platform in Order to Increase TB Treatment Adherence in LMICs PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Each year, 10.4 million patients are diagnosed with and 1.8 million people die from Tuberculosis (TB). Despite the availability of highly effective and accessible medications in the developing world where TB is endemic, the 6-18 month treatment regimen is often thwarted as patients fail to comply due to a lack of knowledge about the disease, desire for privacy, and/or stigma avoidance. Inappropriate medication use leading to multi-drug resistant (MDR) TB infects 5% of all TB patients, yet accounts for a significant proportion of all spending. In Kenya, … |
EREZ YOELI; | 2016-01-04 |
| 112 | A Phase 1 Clinical Trial to Evaluate The Safety and Immunogenicity of A Monovalent Ebola Zaire Vaccine (rVSVN4CT1-EBOVGP1) Delivered By Intramuscular Injection in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response. |
MURRAY A KIMMEL; | 2015-12-22 |
| 113 | A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate The Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of The Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults. |
JANSSEN VACCINES & PREVENTION B V | 2015-12-10 |
| 114 | Safety and Immunogenicity Study of GSK Biologicals’ Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately. Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, … |
GLAXOSMITHKLINE | 2015-11-09 |
| 115 | A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate The Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of The Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata. |
JANSSEN VACCINES & PREVENTION B V | 2015-11-06 |
| 116 | A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate The Safety and Immunogenicity of The Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone. |
ALIE H WURIE; | 2015-10-01 |
| 117 | A Staged Phase 3 Study, Including A Double-Blinded Controlled Stage to Evaluate The Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo As Candidate Prophylactic Vaccines for Ebola PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen. |
JANSSEN VACCINES & PREVENTION B V | 2015-09-30 |
| 118 | A Phase I, Safety and Immunogenicity Trial of The Heterologous Prime-boost Regimen Combining The Monovalent Zaire Ebola Viral Vector Candidates ChAd3-EBO-Z and Ad26.ZEBOV in Healthy UK Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen. All ChAd3-EBO-Z doses are 1×10^11 vp and all Ad26.ZEBOV doses are 5×10^10 vp. Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days later. Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days later. Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days later. Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days later. The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples. The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it. Healthy volunteers will be recruited in Oxford and London, England. The study will be co-funded by GSK Biologicals and Crucell Holland BV. |
UNIVERSITY OF OXFORD | 2015-09-21 |
| 119 | A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study The Safety and Immunogenicity of Three Consistency Lots and A High Dose Lot of RVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, … |
MERCK SHARP & DOHME | 2015-08-17 |
| 120 | Phase 1 Evaluation of A Live Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults. |
KAWSAR TALAAT; | 2015-08-01 |
| 121 | Safety and Immunogenicity Study of GSK Biologicals’ Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study, … |
GLAXOSMITHKLINE | 2015-07-15 |
| 122 | Safety and Immunogenicity of A Booster Dose of The Recombinant Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults After Primary Immunization PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃. In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial was performed in Taizhou, … |
FENG-CAI ZHU; | 2015-07-01 |
| 123 | A Phase Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen. All ChAd3-EBO Z doses are 2.5 x 10^10 – … |
SOULEYMANE MBOUP; | 2015-07-01 |
| 124 | A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate The Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of The Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens. |
JANSSEN VACCINES & PREVENTION B V | 2015-06-15 |
| 125 | Phase 1, Open-Label Study to Evaluate The Safety, Tolerability, and Immunogenicity of INO-4212 and Its Components, INO-4201 and INO-4202, Given With or Without INO-9012, Administered IM or ID Followed By Electroporation in Healthy Volunteers PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well tolerated and immunogenic. |
INOVIO PHARMACEUTICALS | 2015-05-01 |
| 126 | [rVSVΔG-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood and secretions, lack of appropriate personal protective equipment (PPE) and challenges in following infection control and prevention protocols put healthcare workers at high risk during outbreaks, … |
MOHAMED SAMAI; | 2015-04-01 |
| 127 | An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD) |
CHRISTOPHER WOODS; | 2015-04-01 |
| 128 | VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or As Boost to CAd3-Ebola Vaccines in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune response against Ebola. Objectives: – To see if the two new vaccines are safe and if they cause any side effects. Also, to study immune responses to the vaccines. Eligibility: – Healthy adults ages 18-66 Design: – … |
JULIE E LEDGERWOOD; | 2015-03-26 |
| 129 | A Multicenter Randomized Safety and Efficacy Study of Putative Investigational Therapeutics in The Treatment of Patients With Known Ebola Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Ebola is a viral infection that can spread quickly and causes life-threatening disease. Right now there is an Ebola outbreak in many countries in West Africa. There are no approved treatments for Ebola. But possible treatments are being developed. Researchers need to study these treatments to see if they help people get better. Objective: – To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental drugs to advanced Ebola care can reduce the risk of death. Eligibility: – People who have recently been diagnosed with Ebola, … |
RICHARD T DAVEY; | 2015-03-13 |
| 130 | A Phase 1a Open-Label Study to Assess The Safety and Pharmacokinetics of A Single ZMappTM Administration in Healthy Adult Volunteers Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Ebola is a virus that can spread quickly and causes serious disease. It is currently causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a new drug made of natural infection-fighting substances. Researchers want to see if it can treat Ebola. Objective: – To assess the safety of ZMappTM and how the body processes it. To measure the immune system response to ZMappTM. Eligibility: – Healthy people 18 50 years old. Design: – Participants will be screened with a medical history, physical exam, … |
RICHARD T DAVEY; | 2015-03-11 |
| 131 | Clinical Evaluation of The BioFire FilmArray® BioThreat-E Test for The Diagnosis of Ebola Virus Disease in West Africa PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques. |
N’FALLY MAGASSOUBA; | 2015-03-01 |
| 132 | A PHASE IB, DOUBLE-BLIND, CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF TWO DIFFERENT DOSAGE LEVELS OF EBOLA CHIMPANZEE ADENOVIRUS VECTOR VACCINE VRC-EBOADC069-00-VP (cAd3-EBO) AND THE HETEROLOGOUS PRIME-BOOST CANDIDATE VACCINE REGIMEN OF CAD3-EBO FOLLOWED BY MVA-VECTORED VACCINE IN HEALTHY ADULTS, 18-65 YEARS OF AGE, IN BAMAKO, MALI PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers, age 18-65 years (mostly health care workers and other front line workers [e.g., individuals who incinerate contaminated materials]), at one of 2 dosage levels, … |
MILAGRITOS TAPIA; | 2015-03-01 |
| 133 | A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of The Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China. |
LANJUAN LI; | 2015-03-01 |
| 134 | Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will evaluate Convalescent Plasma (CP) added to standardized supportive care (SC) in patients with confirmed Ebola Virus Disease (EVD). No patient will be refused CP when compatible products are available and all efforts will be made to maximize CP availability during the study. EVD patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given SC and will be followed for study outcomes. Data from these SC patients will be the used as comparator in the analysis of the study. The primary objective of the study is to assess if CP + SC improves the 14 day survival of patients, compared to SC alone. The Investigators aim to enroll a total number of 130 – 200 patients who will be treated treated with CP assuming equal numbers of patients treated with SC alone. If there would be insufficient patients treated with SC, patients treated at the research site prior to study start may be included in the comparison group. Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres (MSF) in Conakry, Guinea. All patients and/or relatives presenting at the centre will be informed about the study, and will be invited to provide consent at the time of admission inside the treatment centre. Only patients for whom ebola infection is confirmed with polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility to the intervention will be reassessed on regular intervals. If the eligibility criteria are not met by 48 hours after inclusion, only SC will be continued. In line with the guidance of the World Health Organization (WHO), two units of CP will be given. EVD patients will be transfused with ABO-compatible CP using standard procedures. Details on the modalities of transfusion can be found in the WHO guidance document and the MSF guidelines on blood transfusion. All patients will be under close observation for transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours after the start of transfusion, a blood sample will be collected for viral load assessment. All other aspects of patient management will be according to MSF clinical guidelines. The decision to discharge a patient should be taken on clinical grounds, but can be supported by the laboratory results. After discharge, the patient will be followed up by the study team until day 30. |
NIANKOYE HABA; | 2015-02-01 |
| 135 | A Phase 1, Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate The Immunogenicity and Safety of An Ebola Virus (EBOV) Glycoprotein (GP) Nanoparticle Vaccine, With or Without Matrix-M™ Adjuvant, in Healthy Subjects ≥18 to <50 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, observer-blind, placebo-controlled trial in male and female subjects ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical examination, and baseline clinical laboratory testing. Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups. Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with or without Matrix-M adjuvant), in a 0.5mL injection volume. |
NOVAVAX | 2015-02-01 |
| 136 | Phase 1B, Open-Label, Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of The Investigational Ebola Vaccines, VRC-EBOADC069-00-VP, VRC-EBOADC076-00-VP and VRC-EBOMVA079-00-VP in Healthy Adults in Kampala Uganda PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety, tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2. Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1 will include at least 60 volunteers who have never received an investigational Ebola vaccine. Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30 eligible participants who previously participated in the RV247 vaccine clinical trial and received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine. Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine at the same dose level. |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2015-01-27 |
| 137 | Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Ebola virus disease (EVD) affects many people in Liberia and other countries in West Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting, diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause Ebola. Objectives: – To study the safety and efficacy of two Ebola vaccines. Eligibility: – Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never had Ebola. Design: – … |
H. CLIFFORD LANE; | 2015-01-20 |
| 138 | A Phase 1 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate The Safety and Immunogenicity of The BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola vaccine BPSC-1001 to see if it is safe and to see how it affects people’s immune system. |
MERCK SHARP & DOHME | 2014-12-05 |
| 139 | A Phase 1 Double-blind, Dose-escalation, Clinical Trial to Evaluate The Safety, Tolerability and Immunogenicity of The Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults in China PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃. This is a single center, double-blind, placebo control, … |
FENGCAI ZHU; | 2014-12-01 |
| 140 | Efficacy of Favipiravir in Reducing Mortality in Individuals With Ebola Virus Disease in Guinea PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: There is no specific treatment for Ebola Virus Disease (EVD). Current EVD care are supportive, and includes intravenous or oral rehydration, nutrition, pain killers, treatment of coinfections with antibacterial and antimalarial drugs, and blood transfusion when appropriate. Despite these interventions, mortality remains high since the ongoing Ebola outbreak in West Africa was declared in April. Potential anti-Ebola specific interventions include convalescent plasma, monoclonal and polyclonal antibodies, small inhibitory RNA (siRNA), synthetic adenosine analogues or RNA polymerase inhibitors. All these interventions are considered investigational due to lack of data in humans with EVD. In this study, … |
DENIS MALVY; | 2014-12-01 |
| 141 | A Phase 1, Open-Label, Dose-Escalation Study to Evaluate The Safety and Immunogenicity of The BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders. There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities. There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective. There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, … |
PHILIP BEJON; | 2014-12-01 |
| 142 | A Prospective, Open Label Observational, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this Phase 1 safety study is to provide access to the potential therapeutic benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to plasma from donors who may be infected with other transfusion-transmitted pathogens, not detectable by current licensed donor testing procedures, will be mitigated by using pathogen inactivation to minimize the risk of the TTI from these donors, who would otherwise be deferred and ineligible for blood donation. |
CERUS | 2014-12-01 |
| 143 | Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease. |
EMERGENCY NGO ONLUS | 2014-12-01 |
| 144 | A Phase I/II Dose-finding Randomized, Single-center, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of The Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine BPSC1001 (VSVΔG-ZEBOV) in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevention available at this time. The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials are needed. To accelerate this process, the World Health Organization (WHO) has constituted a consortium of Clinical Research Centers in Switzerland, Germany, … |
SIEGRIST CLAIRE-ANNE; | 2014-11-01 |
| 145 | An Open Label, Single Center, Dose Escalation Phase I Trial to Assess The Safety, Tolerability and Immunogenicity of A Single Ascending Dose of The Ebola Virus Vaccine RVSVΔG-ZEBOV-GP (BPSC1001) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study is designed to establish safety, tolerability and immunogenicity of rVSVΔG-ZEBOV-GP (BPSC1001), an Ebola Virus Vaccine candidate (recombinant vesicular stomatitis virus (VSV) expressing the envelope glycoprotein of Ebola Virus Zaire), investigated at three different dose levels in 30 healthy adults in Germany. This study is part of the WHO led VEBCON consortium that is aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001) vaccine candidate to allow optimized rapid decisions on dose and safety. |
UNIVERSITÄTSKLINIKUM HAMBURG EPPENDORF | 2014-11-01 |
| 146 | A Phase I/II Pilot Clinical Trial to Evaluate The Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for Treatment of EVD PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for treatment of EVD. |
JERRY BROWN; | 2014-11-01 |
| 147 | A Phase 1 Randomized, Single-Center, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate The Safety and Immunogenicity of The BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. Objectives: To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how it affects people’s immune system. Eligibility: – Healthy men and women ages 18-65. They must not have a chronic medical condition that requires medicine. They must not be a healthcare worker, an animal care worker, or a childcare worker, … |
SCOTT HALPERIN; | 2014-11-01 |
| 148 | Efficacy of Favipiravir Against Severe Ebola Virus Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the most difficult aspect for clinical management of EVD due to its high fatality rate. |
WU ZHONG; | 2014-11-01 |
| 149 | A Phase 1 Randomized, Single-Center, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate The Safety and Immunogenicity of The BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001. The purpose of this study is to test how safe the vaccine is in humans and how well it makes the human immune system cause an immune- or defense-response to Ebola virus. This vaccine will be studied at different doses. |
MERCK SHARP & DOHME | 2014-10-13 |
| 150 | A Phase 1 Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate The Safety and Immunogenicity of Prime-Boost VSV Ebola Vaccine in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus (ZEBOV) has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is safe and to see how it affects people’s immune system. |
MERCK SHARP & DOHME | 2014-10-07 |
| 151 | A Phase I/II Double-blind, Randomized, Placebo Controlled, Safety and Immunogenicity, Dose-finding Trial of The Monovalent Zaire Ebola Chimpanzee Adenovirus Vector Candidate Vaccine CAd3-EBOZ in Healthy Adults in Switzerland PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this trial is to assess in healthy adults the safety and reactogenicity of a new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the immunogenicity of the candidate vaccine and find the most suitable dose for further deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of possibly exposed volunteers owning to organisations such as Médecins sans frontières and susceptible to be deployed in the outbreak zone (named as possibly exposed volunteers). The other volunteers will be adults with no planned travels to the epidemic zone (named as not exposed volunteers). The first group will be randomly allocated to two different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp). The second group will be randomly allocated to three different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp or placebo = single injection of vaccine diluent). The design will be double-blind. Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180. |
FRANÇOIS SPERTINI; | 2014-10-01 |
| 152 | A Phase 1b, Dose-escalating Safety and Immunogenicity Trial of The Novel Monovalent Ebola Zaire Candidate Vaccine, CAd3-EBO Z and The Heterologous Prime-boost Candidate Vaccine Regimen of CAD3-EBO Z Followed By MVA-BN® Filo in Malian Adults Aged 18-50 Years PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine. |
MILAGRITOS TAPIA; | 2014-10-01 |
| 153 | An Open-Label, Multicenter Study of The Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses. |
CHIMERIX | 2014-10-01 |
| 154 | An Open-Label, Multicenter Study of The Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease. |
CHIMERIX | 2014-10-01 |
| 155 | A Phase Ia, Dose-Escalating, Safety and Immunogenicity Trial of The Monovalent Zaire Ebola Viral Vector Candidate Vaccine CAd3-EBO Z and The Heterologous Prime-boost Candidate Vaccine Regimen CAd3-EBO Z and MVA-BN® Filo in Healthy UK Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. The investigators will do this by giving volunteers a either one or two vaccinations, … |
ADRIAN V HILL; | 2014-09-17 |
| 156 | VRC 207: A Phase I/1b, Open-Label, Dose-Escalation Clinical Trial to Evaluate The Safety, Tolerability and Immunogenicity of The Ebola Chimpanzee Adenovirus Vector Vaccines, VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ), in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine. Objectives: – To see if an Ebola vaccine is safe and to study immune responses to it. Eligibility: – Healthy adults ages 18-65. Design: – Participants will be screened through a separate protocol. – … |
JULIE E LEDGERWOOD; | 2014-08-27 |
| 157 | Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Increased clinical attention has been paid to the evaluation and management of bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases (such as Severe Acute Respiratory Syndrome \[SARS\] and new strains of influenza). However, evaluation and treatment data for these illnesses are often limited because human infections to date have been relatively limited. Further knowledge about diseases of bioterrorism concern and emerging infectious diseases may lead to more effective forms of therapy to prevent disease-related illnesses and deaths. Objectives: – To apply standardized, documented, and carefully monitored evaluation and treatment methods for bioterrorism- … |
RICHARD T DAVEY; | 2011-08-04 |
| 158 | Therapeutic Safety and Efficacy of REP 2139 (REP 9AC’) in HBV Infected Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent therapeutic effect against established DHBV infection in vivo REP 2055 was additionally shown to have significant antiviral effects in patients with chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055 designed for improved administration tolerability and stability. The safety and antiviral activity REP 2139, … |
MAMUN AL-MAHTAB; | 2011-08-01 |
| 159 | A Phase I Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess The Safety, Tolerability and Pharmacokinetics of AVI-6002 in Healthy Adult Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus. |
WILLIAM B SMITH; | 2010-05-01 |
| 160 | A Phase IB Study to Evaluate The Safety and Immunogenicity of An Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and A Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults in Kampala, Uganda PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them. |
HANNAH KIBUUKA; | 2010-02-01 |
| 161 | Therapeutic Safety and Efficacy of REP 9AC (REP 2055) in HBV or HCV Infected Patients Related Papers Related Patents Related Grants Related Experts View Highlight: REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry activity against hepatitis C virus and entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent prophylactic effect against HCV infection in vivo and potent therapeutic effect against established DHBV infection in vivo The REP 101 protocol is the first-in-man proof of concept study designed to investigate the safety and antiviral activity of REP 2055 administration in human patients with chronic HBV or HCV infection. |
MAMUN AL-MAHTAB; | 2009-01-01 |
| 162 | A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate The Safety and Tolerability of Topical Nasal Poly-ICLC PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels. Healthy people between 18 and 70 years of age who have no chronic medical problems may be eligible for this study. Participants undergo the following procedures: Part I – Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. – … |
RICHARD T DAVEY; | 2008-03-24 |
| 163 | VRC 206: A Phase I Study to Evaluate The Safety and Immunogenicity of An Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and A Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2008-01-25 |
| 164 | A Phase I Clinical Trial to Evaluate The Safety and Immunogenicity of A Recombinant Ebola Adenoviral Vector Vaccine, VRC-EBOADV018-00-VP, in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2006-09-05 |
| 165 | VRC 204 A Phase I Clinical Trial to Evaluate The Safety and Immunogenicity of A Multiple Strain Ebola DNA Plasmid Vaccine, VRC-EBODNA012-00-VP, in Adult Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock. The infection may be mild, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2003-10-30 |