Status:
TERMINATED
TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)
Lead Sponsor:
Hospital Italiano de Buenos Aires
Collaborating Sponsors:
Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
Conditions:
Healthcare Workers
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-...
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 h...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Having symptoms compatible with COVID-19
- Diagnosed HIV infection
- Current use of Pre-exposure prophylaxis for HIV
- Diagnosed Hepatitis B infection.
- Diagnosed renal insufficiency and or current hemodialysis need
- Diagnosed osteoporosis under pharmacological treatment.
- Weight \< 40kg
- Current immunosuppressive or serious hematological condition
- Prior use of pre-exposure prophylaxis for SARS-CoV-2
- Current pregnancy or pregnancy plan within the study course.
- Current breastfeeding
- Known hypersensitivity to any of the study medication components.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2020
Estimated Enrollment :
1378 Patients enrolled
Trial Details
Trial ID
NCT04405271
Start Date
July 31 2020
End Date
November 15 2020
Last Update
September 9 2025
Active Locations (1)
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1
Sociedad Argentina de Infectología, A. J. Carranza 974
Buenos Aires, Buenos Aires F.D., Argentina, C1085