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EPICOS: PrEP for COVID-19 in Healthcare Workers
NCT04334928Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2020
- Primary completion
- Feb 2021
- Countries
- 1
- Sponsor
- Plan Nacional sobre el Sida
- Modality
- Small Molecules
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial of emtricitabine + tenofovir disoproxil and hydroxychloroquine in coronavirus disease 2019 (COVID-19) (4 arms), sponsored by Plan Nacional sobre el Sida. Primary endpoint: Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19) at 12 weeks. Started Apr 2020; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
TDF/FTC
Emtricitabine/Tenofovir + Placebo HC
HCQ
Hydroxychloroquine + Placebo TDF/FTC
TDF/FTC + HCQ
Emtricitabine/Tenofovir + Hydroxychloroquine
Placebo
Double Placebo
03
Who it enrols
Healthcare workers aged 18-70 without prior COVID-19 diagnosis or symptoms. Excludes HIV, active Hepatitis B, renal failure (GFR < 60), osteoporosis, myasthenia gravis, pre-existent maculopathy, retinitis pigmentosa, bradycardia < 50bpm, weight < 40kg, and use of QT-prolonging drugs.
04
Endpoints
Primary
Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19)
Secondary
Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19)
Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19)
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