Pre-exposure prophylaxis with hydroxychloroquine for COVID-19 : a double-blind, placebo-controlled randomized clinical trial
Grau-Pujol, Berta (Institut de Salut Global de Barcelona)
Camprubí-Ferrer, D. (Institut de Salut Global de Barcelona)
Marti-Soler, H. (Institut de Salut Global de Barcelona)
Fernández-Pardos, M. (Institut de Salut Global de Barcelona)
Carreras-Abad, Clara (Institut de Salut Global de Barcelona)
Velasco de Andrés, María (Institut de Salut Global de Barcelona)
Ferrer, E. (Institut de Salut Global de Barcelona)
Muelas-Fernandez, M. (Institut de Salut Global de Barcelona)
Jullien, S. (Institut de Salut Global de Barcelona)
Barilaro, G. (Institut de Salut Global de Barcelona)
Ajanovic, S. (Institut de Salut Global de Barcelona)
Vera, I. (Institut de Salut Global de Barcelona)
Moreno, L. (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Gonzalez-Redondo, E. (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Cortés Serra, Núria (Institut de Salut Global de Barcelona)
Roldán, M. (Institut de Salut Global de Barcelona)
Arcos, A. A. d. (Institut de Salut Global de Barcelona)
Mur, Isabel (Institut d'Investigació Biomèdica Sant Pau)
Domingo, Pere (Institut d'Investigació Biomèdica Sant Pau)
Garcia, F. (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Guinovart, C. (Institut de Salut Global de Barcelona)
Muñoz, J. (Institut de Salut Global de Barcelona)
Universitat Autònoma de Barcelona

Data:	2021
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 COVID-19. 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). Conclusions: Although the efficacy of PrEP with hydroxychloroquine for preventing COVID-19 could not be evaluated, our study showed that PrEP with hydroxychloroquine at low doses is safe. Trial registration: ClinicalTrials. govNCT04331834. Registered on April 2, 2020.
Ajuts:	Agencia Estatal de Investigación CEX2018-000806-S
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Hydroxychloroquine ; COVID-19 ; Pre-exposure prophylaxis ; Prevention ; Health-care workers ; Control ; SARS-CoV-2
Publicat a:	Trials, Vol. 22 Núm. 1 (december 2021) , p. 808, ISSN 1745-6215

DOI: 10.1186/s13063-021-05758-9
PMID: 34781981

10 p, 800.2 KB

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