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PEP CoV-2 Study
NCT04304053Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2020
- Primary completion
- Jun 2020
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- hydroxychloroquine
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, open-label trial of hydroxychloroquine in coronavirus disease 2019 (COVID-19) (2 arms). Primary endpoints: Clinical and virological outcome in exposed contacts at 14 days, Transmission of SARS-CoV-2 in exposed contacts at 14 days and 2 more. Started Mar 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
No Intervention
Standard Public Health measures
Hydroxychloroquine
Treatment and prophylaxis with Hydroxychloroquine
03
Who it enrols
Adults aged 18+ who are either asymptomatic contacts of a COVID-19 case (Study 1) or non-severe confirmed COVID-19 cases (Study 2). Excludes pregnant/lactating women, and those with significant liver/kidney disease, cardiac arrhythmia, psoriasis, myasthenia, retinal diseases, or G6PD deficiency.
04
Endpoints
Primary
Clinical and virological outcome in exposed contacts
Transmission of SARS-CoV-2 in exposed contacts
Virological outcome in index cases
Clinical outcome in index cases
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