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