Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

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

drug

Placebo

A dose of 1 tablet per day will be administered for a total of 12 weeks.

Ubicaciones

Sociedad Argentina de Infectología, A. J. Carranza 974

Buenos Aires, Buenos Aires F.D., Argentina

Patrocinadores

PrincipalHospital Italiano de Buenos Aires

ColaboradorSociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)

Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)