NCT04405271

TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)

Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,378 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.

Detailed description

Randomized, double-blind, placebo-controlled clinical trial. Phase III clinical trial for a new indication Rationale One of the most affected subgroups during the current pandemic is represented by healthcare workers. In Argentina between 14 and 17% of the total COVID-19 cases are represented by this subgroup. In this sense, it appears as an adequate strategy testing the efficacy of pharmacological PrEP approaches on top of the currently recommended control measures. The use of placebo is warranted for two main reasons: all healthcare workers will be allowed and encouraged to comply with non-pharmacological infection control measures for the protection of viral transmission. On the other hand, the use of a blinded placebo is intended for avoiding relaxation of the non-pharmacological control measures. Tenofovir has been identified by both docking and in vitro studies as an inhibitor of RdRp (RNA dependent RNA polymerase) of coronavirus. FTC/TAF has the additional advantage that is already being used in a pre-exposure prophylaxis setting and its safety is widely known. Main objective To evaluate the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.

Conditions

• Healthcare Workers
• COVID-19
• SARS-CoV 2

Interventions

Type	Name	Description
DRUG	Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet	Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks
DRUG	Placebo	A dose of 1 tablet per day will be administered for a total of 12 weeks.

Timeline

• Start date: 2020-07-31
• Primary completion: 2020-11-15
• Completion: 2020-11-15
• First posted: 2020-05-28
• Last updated: 2025-09-09

Locations

1 site across 1 country: Argentina