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

• Status: Not yet recruiting
• Trial end date: 2020-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Italiano de Buenos Aires
• Collaborator: Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Tenofovir

Criteria

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.

11. Current breastfeeding

12. Known hypersensitivity to any of the study medication components.