Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
PREVAIL IV: A Randomized, Double-Blind, 2-Phase, Phase 2 Trial of Remdesivir vs Placebo for Reduction of Ebola Virus RNA in the Semen of Male Survivors.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02818582 (PREVAIL IV), which is not on this map. Cited by 17 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
17 citing papers in PubMed, 40 citations in OpenAlex.
- A case of Bundibugyo virus disease treated with monoclonal antibodies and remdesivir.Nature medicine · 2026Article
- Viral threats to pregnancy: Global health risks in the era of pandemics.Advances in virus research · 2026Review
- Review
- Article
- Understanding Ethical Concerns Involving Vulnerable Human Participant Populations in Medical Research: Mixed-Method Analysis of Liberian Ebola Survivors' Experiences in PREVAIL I-VII.Healthcare (Basel, Switzerland) · 2024Article
- SARS-CoV-2 resistance to monoclonal antibodies and small-molecule drugs.Cell chemical biology · 2024Review
- Review
- Perspectives on Advancing Countermeasures for Filovirus Disease: Report From a Multisector Meeting.The Journal of infectious diseases · 2023Article
- Filoviruses: Scientific Gaps and Prototype Pathogen Recommendation.The Journal of infectious diseases · 2023Review
- Clinically Evaluated COVID-19 Drugs with Therapeutic Potential for Biological Warfare Agents.Microorganisms · 2023Review
- Effect of remdesivir post-exposure prophylaxis and treatment on pathogenesis of measles in rhesus macaques.Scientific reports · 2023Article
- Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries.Wellcome open research · 2023Article
- The Evolution of Medical Countermeasures for Ebola Virus Disease: Lessons Learned and Next Steps.Vaccines · 2022Article
- The development of broad-spectrum antiviral medical countermeasures to treat viral hemorrhagic fevers caused by natural or weaponized virus infections.PLoS neglected tropical diseases · 2022Review
- Why Remdesivir Failed: Preclinical Assumptions Overestimate the Clinical Efficacy of Remdesivir for COVID-19 and Ebola.Antimicrobial agents and chemotherapy · 2021Article
- Contemporary narrative review of treatment options for COVID-19.Respirology (Carlton, Vic.) · 2021Review
- Review
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Authors and funding
14 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundEbola virus RNA persists in the semen of male Ebola survivors for months to years after the acute infection, and male-to-female sexual transmission of the virus is well documented. We investigated whether remdesivir can safely reduce persistence of seminal Ebola virus RNA.
methodsWe recruited men with persistent seminal Ebola RNA in Liberia and Guinea. Participants were randomized 1:1 to receive intravenous remdesivir (GS-5734; Gilead Sciences) or matching placebo administered once daily by intravenous infusion over 1 hour on 5 consecutive days. Stratification was by country and number of positive (1 or 2) preenrollment semen tests. We evaluated the difference in mean assay negativity rate (ANR), that is, the proportion of negative tests for each participant in each group in the treatment (days 1-28) and follow-up (months 2-6) phases on an intention-to-treat basis.
resultsWe enrolled 38 men from July 2016 through June 2018. The mean treatment phase ANRs were 85% (standard deviation [SD] = 24%) and 76% (SD = 30%) in the remdesivir and placebo arms, respectively (P = .270). The mean follow-up phase ANRs were 96% (SD = 10%) and 81% (SD = 29%) in the remdesivir and placebo arms, respectively (P = .041). The 5-day remdesivir regimen was well tolerated with no safety concerns.
conclusionsIn this small trial, remdesivir 100 mg/day for 5 days safely reduced the presence of Ebola virus RNA in the semen of Ebola survivors 2 to 6 months after administration. A larger follow-up study is necessary to confirm results. Clinical Trials Registration . NCT02818582.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.