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

Abstract 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...

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Autores principales:	Berta Grau-Pujol, Daniel Camprubí-Ferrer, Helena Marti-Soler, Marc Fernández-Pardos, Clara Carreras-Abad, Maria Velasco-de Andrés, Elisabet Ferrer, Magdalena Muelas-Fernandez, Sophie Jullien, Giuseppe Barilaro, Sara Ajanovic, Isabel Vera, Laura Moreno, Eva Gonzalez-Redondo, Núria Cortes-Serra, Montserrat Roldán, Ana Artes-de Arcos, Isabel Mur, Pere Domingo, Felipe Garcia, Caterina Guinovart, Jose Muñoz
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Hydroxychloroquine COVID-19 Pre-exposure prophylaxis Prevention Health-care workers Control Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/2b4c20b3728740f1b490dccab7dd5a8a
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spelling	oai:doaj.org-article:2b4c20b3728740f1b490dccab7dd5a8a2021-11-21T12:31:31ZPre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial10.1186/s13063-021-05758-91745-6215https://doaj.org/article/2b4c20b3728740f1b490dccab7dd5a8a2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05758-9https://doaj.org/toc/1745-6215Abstract 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.gov NCT04331834 . Registered on April 2, 2020.Berta Grau-PujolDaniel Camprubí-FerrerHelena Marti-SolerMarc Fernández-PardosClara Carreras-AbadMaria Velasco-de AndrésElisabet FerrerMagdalena Muelas-FernandezSophie JullienGiuseppe BarilaroSara AjanovicIsabel VeraLaura MorenoEva Gonzalez-RedondoNúria Cortes-SerraMontserrat RoldánAna Artes-de ArcosIsabel MurPere DomingoFelipe GarciaCaterina GuinovartJose MuñozBMCarticleHydroxychloroquineCOVID-19Pre-exposure prophylaxisPreventionHealth-care workersControlMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Hydroxychloroquine COVID-19 Pre-exposure prophylaxis Prevention Health-care workers Control Medicine (General) R5-920
spellingShingle	Hydroxychloroquine COVID-19 Pre-exposure prophylaxis Prevention Health-care workers Control Medicine (General) R5-920 Berta Grau-Pujol Daniel Camprubí-Ferrer Helena Marti-Soler Marc Fernández-Pardos Clara Carreras-Abad Maria Velasco-de Andrés Elisabet Ferrer Magdalena Muelas-Fernandez Sophie Jullien Giuseppe Barilaro Sara Ajanovic Isabel Vera Laura Moreno Eva Gonzalez-Redondo Núria Cortes-Serra Montserrat Roldán Ana Artes-de Arcos Isabel Mur Pere Domingo Felipe Garcia Caterina Guinovart Jose Muñoz Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
description	Abstract 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.gov NCT04331834 . Registered on April 2, 2020.
format	article
author	Berta Grau-Pujol Daniel Camprubí-Ferrer Helena Marti-Soler Marc Fernández-Pardos Clara Carreras-Abad Maria Velasco-de Andrés Elisabet Ferrer Magdalena Muelas-Fernandez Sophie Jullien Giuseppe Barilaro Sara Ajanovic Isabel Vera Laura Moreno Eva Gonzalez-Redondo Núria Cortes-Serra Montserrat Roldán Ana Artes-de Arcos Isabel Mur Pere Domingo Felipe Garcia Caterina Guinovart Jose Muñoz
author_facet	Berta Grau-Pujol Daniel Camprubí-Ferrer Helena Marti-Soler Marc Fernández-Pardos Clara Carreras-Abad Maria Velasco-de Andrés Elisabet Ferrer Magdalena Muelas-Fernandez Sophie Jullien Giuseppe Barilaro Sara Ajanovic Isabel Vera Laura Moreno Eva Gonzalez-Redondo Núria Cortes-Serra Montserrat Roldán Ana Artes-de Arcos Isabel Mur Pere Domingo Felipe Garcia Caterina Guinovart Jose Muñoz
author_sort	Berta Grau-Pujol
title	Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
title_short	Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
title_full	Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
title_fullStr	Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
title_full_unstemmed	Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
title_sort	pre-exposure prophylaxis with hydroxychloroquine for covid-19: a double-blind, placebo-controlled randomized clinical trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/2b4c20b3728740f1b490dccab7dd5a8a
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Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial

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