COVID-19 Clinical Trial
Official title:
Treatment of Non-severe Confirmed Cases of COVID-19 and Chemoprophylaxis of Their Contacts as Prevention Strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study)
This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2).
Hydroxychloroquine (HCQ) is a drug that has been extensively used for the prevention of
malaria. HCQ showed excellent in vitro results and strong antiviral effects on SARS-CoV-2
infection of primate cells at low concentration. Empirical data for the efficacy of HCQ in
hospitalized Covid-19 patients became available after the start of this study; HCQ
administration did not result in a significantly higher PCR negative conversion in a RCT
including 150 patients and there was no reduction in the risk of death/intubation in two
large observational studies.
Study 1 -We investigated the efficacy and safety of HCQ to prevent secondary SARS-CoV-2
infection and Covid-19 disease in contacts exposed to a PCR-positive Covid-19 case during.
Study 2- We also conducted a study to test the hypothesis that HCQ treatment would be more
efficacious than no-treatment for patients with mild Covid-19.
Initially, the protocol included the use of combined treatment with a HIV protease inhibidor
(cobicistat-boosted darunavir) for cases (study 2), but it was adapted to HCQ alone after the
recommendation of the pharmaceutical company not to use DRVc for the treatment of Covid-19
due to lack of activity in-vitro.
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