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.
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.