Pre-exposure prophylaxis with hydroxychloroquine for COVID-19

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...

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Authors: Grau-Pujol, Berta|||0000-0002-7320-0965, Camprubí-Ferrer, Daniel, Marti-Soler, Helena, Fernández-Pardos, Marc, Carreras-Abad, Clara|||0000-0002-9068-3233, Velasco de Andrés, María|||0000-0003-1230-3845, Ferrer, Elisabet|||0000-0002-0900-5436, Muelas-Fernandez, Magdalena, Jullien, Sophie, Barilaro, Giuseppe, Ajanovic, Sara, Vera-Garcia, Isabel, Moreno, Laura, Gonzalez-Redondo, Eva, Cortés Serra, Núria|||0000-0001-5396-3757, Roldán, Montserrat, Artes-de Arcos, Ana, Mur, Isabel|||0000-0001-7660-8483, Domingo Pedrol, Pedro|||0000-0003-1138-5770, García, Felipe|||0000-0001-7658-5832, Guinovart, Caterina, Muñoz Gutiérrez, José|||0000-0002-0945-1735
Format: article
Publication Date:2021
Country:España
Institution:Universitat Autònoma de Barcelona
Repository:Dipòsit Digital de Documents de la UAB
Language:English
OAI Identifier:oai:ddd.uab.cat:264646
Online Access:https://ddd.uab.cat/record/264646
https://dx.doi.org/urn:doi:10.1186/s13063-021-05758-9
Access Level:Open access
Keyword:Hydroxychloroquine
COVID-19
Pre-exposure prophylaxis
Prevention
Health-care workers
Control
SARS-CoV-2
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repository_id_str
spelling Pre-exposure prophylaxis with hydroxychloroquine for COVID-19a double-blind, placebo-controlled randomized clinical trialGrau-Pujol, Berta|||0000-0002-7320-0965Camprubí-Ferrer, DanielMarti-Soler, HelenaFernández-Pardos, MarcCarreras-Abad, Clara|||0000-0002-9068-3233Velasco de Andrés, María|||0000-0003-1230-3845Ferrer, Elisabet|||0000-0002-0900-5436Muelas-Fernandez, MagdalenaJullien, SophieBarilaro, GiuseppeAjanovic, SaraVera-Garcia, IsabelMoreno, LauraGonzalez-Redondo, EvaCortés Serra, Núria|||0000-0001-5396-3757Roldán, MontserratArtes-de Arcos, AnaMur, Isabel|||0000-0001-7660-8483Domingo Pedrol, Pedro|||0000-0003-1138-5770García, Felipe|||0000-0001-7658-5832Guinovart, CaterinaMuñoz Gutiérrez, José|||0000-0002-0945-1735HydroxychloroquineCOVID-19Pre-exposure prophylaxisPreventionHealth-care workersControlSARS-CoV-2Background: 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.Universitat Autònoma de Barcelona 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/264646https://dx.doi.org/urn:doi:10.1186/s13063-021-05758-9reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengAgencia Estatal de Investigación https://doi.org/10.13039/501100011033 CEX2018-000806-Sopen accesshttp://purl.org/coar/access_right/c_abf2Aquest 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.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2646462026-06-06T12:50:31Z
dc.title.none.fl_str_mv Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
a double-blind, placebo-controlled randomized clinical trial
title Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
spellingShingle Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
Grau-Pujol, Berta|||0000-0002-7320-0965
Hydroxychloroquine
COVID-19
Pre-exposure prophylaxis
Prevention
Health-care workers
Control
SARS-CoV-2
title_short Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
title_full Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
title_fullStr Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
title_full_unstemmed Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
title_sort Pre-exposure prophylaxis with hydroxychloroquine for COVID-19
dc.creator.none.fl_str_mv Grau-Pujol, Berta|||0000-0002-7320-0965
Camprubí-Ferrer, Daniel
Marti-Soler, Helena
Fernández-Pardos, Marc
Carreras-Abad, Clara|||0000-0002-9068-3233
Velasco de Andrés, María|||0000-0003-1230-3845
Ferrer, Elisabet|||0000-0002-0900-5436
Muelas-Fernandez, Magdalena
Jullien, Sophie
Barilaro, Giuseppe
Ajanovic, Sara
Vera-Garcia, Isabel
Moreno, Laura
Gonzalez-Redondo, Eva
Cortés Serra, Núria|||0000-0001-5396-3757
Roldán, Montserrat
Artes-de Arcos, Ana
Mur, Isabel|||0000-0001-7660-8483
Domingo Pedrol, Pedro|||0000-0003-1138-5770
García, Felipe|||0000-0001-7658-5832
Guinovart, Caterina
Muñoz Gutiérrez, José|||0000-0002-0945-1735
author Grau-Pujol, Berta|||0000-0002-7320-0965
author_facet Grau-Pujol, Berta|||0000-0002-7320-0965
Camprubí-Ferrer, Daniel
Marti-Soler, Helena
Fernández-Pardos, Marc
Carreras-Abad, Clara|||0000-0002-9068-3233
Velasco de Andrés, María|||0000-0003-1230-3845
Ferrer, Elisabet|||0000-0002-0900-5436
Muelas-Fernandez, Magdalena
Jullien, Sophie
Barilaro, Giuseppe
Ajanovic, Sara
Vera-Garcia, Isabel
Moreno, Laura
Gonzalez-Redondo, Eva
Cortés Serra, Núria|||0000-0001-5396-3757
Roldán, Montserrat
Artes-de Arcos, Ana
Mur, Isabel|||0000-0001-7660-8483
Domingo Pedrol, Pedro|||0000-0003-1138-5770
García, Felipe|||0000-0001-7658-5832
Guinovart, Caterina
Muñoz Gutiérrez, José|||0000-0002-0945-1735
author_role author
author2 Camprubí-Ferrer, Daniel
Marti-Soler, Helena
Fernández-Pardos, Marc
Carreras-Abad, Clara|||0000-0002-9068-3233
Velasco de Andrés, María|||0000-0003-1230-3845
Ferrer, Elisabet|||0000-0002-0900-5436
Muelas-Fernandez, Magdalena
Jullien, Sophie
Barilaro, Giuseppe
Ajanovic, Sara
Vera-Garcia, Isabel
Moreno, Laura
Gonzalez-Redondo, Eva
Cortés Serra, Núria|||0000-0001-5396-3757
Roldán, Montserrat
Artes-de Arcos, Ana
Mur, Isabel|||0000-0001-7660-8483
Domingo Pedrol, Pedro|||0000-0003-1138-5770
García, Felipe|||0000-0001-7658-5832
Guinovart, Caterina
Muñoz Gutiérrez, José|||0000-0002-0945-1735
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Hydroxychloroquine
COVID-19
Pre-exposure prophylaxis
Prevention
Health-care workers
Control
SARS-CoV-2
topic Hydroxychloroquine
COVID-19
Pre-exposure prophylaxis
Prevention
Health-care workers
Control
SARS-CoV-2
description 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.
publishDate 2021
dc.date.none.fl_str_mv 2
2021-01-01
2021
2021-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/264646
https://dx.doi.org/urn:doi:10.1186/s13063-021-05758-9
url https://ddd.uab.cat/record/264646
https://dx.doi.org/urn:doi:10.1186/s13063-021-05758-9
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Agencia Estatal de Investigación https://doi.org/10.13039/501100011033 CEX2018-000806-S
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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