TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study) (NCT04405271) | Clinical Trial Compass
TerminatedPhase 3
TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)
Stopped: Vaccine availability precluded further recruitment
Argentina1,378 participantsStarted 2020-07-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Healthcare workers voluntarily deciding to participate in the study
✓. Understanding the study purpose
✓. Having between 18 and 70 years old
✓. 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.
✓. Not having a prior diagnosis of SARS-CoV-2 infection (COVID-19)
✓. Having a negative IgM/IgG antibodies test for SARS-CoV-2 (COVID-19) prior to study entry
✓. Negative pregnancy test for childbearing age women within 7 days prior to study entry.
✓. 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.