Trial design
SARS-CoV-2 infection
VIRUS, SARS-COV-2 INFECTION
The study was a pragmatic, randomised, open-label, controled, phase 3 clinical trial evaluating two parallel arms, allocated in a 1:1 ratio, for pre-exposure prevention of SARS-CoV-2 infection in healthcare workers. The study was conducted from July to November 2020. The study consisted of eight (plus baseline) weekly visits to assess seroconversion of antibodies to SARS-CoV-2 or the presence of the virus after presenting with symptoms compatible with COVID-19. The study was approved by the Transitory National Committee of Ethics in Research (CNTEI, acronym in Spanish) as process number CNTEI-003-200. The trial is registered in the Clinical Trials Registry (NCT04414241). The study adheres to the CONSORT Guidelines.