TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)
NCT ID: NCT04405271
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1378 participants
INTERVENTIONAL
2020-07-31
2020-11-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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FTC/TAF
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.
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
Placebo
Identical tablets to the active experimental tablets with the same characteristics and packaging. A dose of 1 tablet per day will be administered for a total of 12 weeks
Placebo
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Interventions
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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
Placebo
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
11. Current breastfeeding
12. Known hypersensitivity to any of the study medication components.
18 Years
ALL
Yes
Sponsors
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Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
UNKNOWN
Hospital Italiano de Buenos Aires
OTHER
Responsible Party
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Waldo Horacio Belloso
Principal Investigator
Principal Investigators
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Waldo H Belloso, MD
Role: STUDY_CHAIR
Hospital Italiano de Buenos Aires
Ventura Simonovich, MD
Role: PRINCIPAL_INVESTIGATOR
HIBA
Esteban Nannini, MD
Role: PRINCIPAL_INVESTIGATOR
Sanatorio Britanico
Wanda Cornistein, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Austral
Marcelo Figueiras, MD
Role: PRINCIPAL_INVESTIGATOR
Richmond Laboratorio
Elvira Zini, MD
Role: PRINCIPAL_INVESTIGATOR
Richmond Laboratorio
Fernando Riera, MD
Role: PRINCIPAL_INVESTIGATOR
Sanatorio Allende (Córdoba)
Omar Sued, MD
Role: PRINCIPAL_INVESTIGATOR
HUESPED
Santiago Ramirez Borga, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Italiano de La Plata
Gustavo Costilla Campero, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Padilla (Tucumán)
Gustavo D Lopardo, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Bernardo Houssay
Gonzalo Corral, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Alende (Mar del Plata)
Locations
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Sociedad Argentina de Infectología, A. J. Carranza 974
Buenos Aires, Buenos Aires F.D., Argentina
Countries
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References
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Elfiky AA. Anti-HCV, nucleotide inhibitors, repurposing against COVID-19. Life Sci. 2020 May 1;248:117477. doi: 10.1016/j.lfs.2020.117477. Epub 2020 Feb 28.
Castillo-Mancilla JR, Meditz A, Wilson C, Zheng JH, Palmer BE, Lee EJ, Gardner EM, Seifert S, Kerr B, Bushman LR, MaWhinney S, Anderson PL. Reduced immune activation during tenofovir-emtricitabine therapy in HIV-negative individuals. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):495-501. doi: 10.1097/QAI.0000000000000529.
Related Links
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Sala de Situación Coronavirus online - Ministerio de Salud de la Nación
Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China
THE PHASE 3 DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS
1962\. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial
Other Identifiers
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5616
Identifier Type: -
Identifier Source: org_study_id
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