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.
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.
Drug: 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
Other Name: FTC/TAF
Drug: Placebo
A dose of 1 tablet per day will be administered for a total of 12 weeks.
Other Name: Placebo comparator
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.
Sociedad Argentina de Infectología, A. J. Carranza 974
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina
Investigator: Waldo H Belloso, MD
Contact: +541149590200
waldo.belloso@hiba.org.ar
Waldo H Belloso, MD
+541149590200
waldo.belloso@hiba.org.ar
Gustavo D Lopardo, MD
+541149590200
glopardo@intramed.net