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2021-11-15

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cc-by (c) Grau Pujol, Berta et al., 2021
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/185968

Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial.

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https://doi.org/10.1186/s13063-021-05758-9

Resum

Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period. Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400 mg of hydroxychloroquine daily for the first four consecutive days and subsequently, 400 mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Given the national epidemic incidence decay, only one participant in each group was diagnosed with COVID19. The trial was stopped due to futility and our study design was deemed underpowered to evaluate any benefit regarding PrEP efficacy. Both groups showed a similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041).

Matèries

COVID-19, SARS-CoV-2, Medicina preventiva, Personal sanitari, Assaigs clínics de medicaments

Matèries (anglès)

COVID-19, SARS-CoV-2, Preventive medicine, Medical personnel, Drug testing

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Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

Citació

GRAU PUJOL, Berta, CAMPRUBÍ FERRER, Daniel, MARTI SOLER, Helena, FERNÁNDEZ PARDOS, Marc, CARRERAS ABAD, Clara, VELASCO DE ANDRÉS, María, FERRER, Elisabet, MUELAS FERNANDEZ, Magdalena, JULLIEN, Sophie, BARILARO, Giuseppe, AJANOVIC, Sara, VERA, Isabel, MORENO, Laura, GONZALEZ REDONDO, Eva, CORTES SERRA, Núria, Roldán Montserrat, ARTES DE ARCOS, Ana, MUR, Isabel, DOMINGO, Pere (domingo pedrol), Garcia Felipe, GUINOVART, Caterina, MUÑOZ GUTIÉRREZ, José. Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial.. _Trials_. 2021. Vol. 22, núm. 1, pàgs. 808. [consulta: 23 de gener de 2026]. ISSN: 1745-6215. [Disponible a: https://hdl.handle.net/2445/185968]

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