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TERMINATEDPHASE3

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)

NCT04405271•Hospital Italiano de Buenos Aires

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthcare workers voluntarily deciding to participate in the study
•2. Understanding the study purpose
•3. Having between 18 and 70 years old
•4. Having a high transmission risk for Covid-19. Physicians, nurses, lab technicians, physical therapists, or cleaning personnel working at COVID-19 areas, hospital emergency areas, or Intensive care units from healthcare institutions with the direct assistance of patients with Covid-19.
•5. Not having a prior diagnosis of SARS-CoV-2 infection (COVID-19)
•6. Having a negative IgM/IgG antibodies test for SARS-CoV-2 (COVID-19) prior to study entry
•7. Negative pregnancy test for childbearing age women within 7 days prior to study entry.
•8. Childbearing age males and females should comply with the use of a proven contraceptive method (double barrier methods, oral contraceptives or contraceptive hormone implants) during the course of the study and at least one month after study completion.

Exclusion Criteria

•1. Having symptoms compatible with COVID-19
•2. Diagnosed HIV infection
•3. Current use of Pre-exposure prophylaxis for HIV
•4. Diagnosed Hepatitis B infection.
•5. Diagnosed renal insufficiency and or current hemodialysis need
•6. Diagnosed osteoporosis under pharmacological treatment.
•7. Weight \< 40kg
•8. Current immunosuppressive or serious hematological condition
•9. Prior use of pre-exposure prophylaxis for SARS-CoV-2
•10. Current pregnancy or pregnancy plan within the study course.
+2 more criteria

Locations (1)

Sociedad Argentina de Infectología, A. J. Carranza 974

Buenos Aires, Buenos Aires F.D., Argentina

Key Dates

Start Date

July 31, 2020

Primary Completion Date

November 15, 2020

Completion Date

November 15, 2020

Last Updated

September 9, 2025

Enrollment

1,378

ACTUAL participants

Conditions

Healthcare WorkersCOVID-19SARS-CoV 2

Interventions

Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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