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PREVAIL IV: Remdesivir for Ebola Virus Persistence in Semen
NCT02818582Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2016
- Primary completion
- Aug 2020
- Countries
- 2
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- remdesivir
- Conditions
- Ebola virus disease (EVD)
01
Overview
Phase 2, randomised, double-blind trial in Ebola virus disease (EVD) comparing Remdesivir Arm with Placebo Arm (2 arms). Primary endpoints: Mean Assay Negativity Rate for Ebola Virus During the Treatment Phase at Day 28 and Mean Assay Negativity Rate for Ebola Virus During the Follow-up Phase at Week 24. Started Jul 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Remdesivir Arm
GS-5734 100mg IV daily for 5 days.
Placebo Arm
Normal saline IV daily for 5 days.
03
Who it enrols
Male Ebola survivors aged 18+ with persistent Ebola virus RNA in semen, normal renal and liver function, and willing to comply with follow-up and condom use.
04
Endpoints
Primary
Mean Assay Negativity Rate for Ebola Virus During the Treatment Phase
Mean Assay Negativity Rate for Ebola Virus During the Follow-up Phase
Secondary
Mean Change From Baseline in ALT Value
Mean Change From Baseline in AST Value
Mean Change From Baseline in aPTT Value
Mean Change From Baseline in INR Value
Mean Change From Baseline in PT Value
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of Participants With Increase in Grade From Baseline for AST Value
Participants With Grade 1-4 ALT Level
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