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Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial

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dc.contributor.author Llanos Cuentas, Elmer Alejandro
dc.contributor.author Schwalb Calderon, Alvaro
dc.contributor.author Quintana Ruiz, Juan Luis
dc.contributor.author Delfin, Brian
dc.contributor.author Alvarez Romero, Fiorela Yuli
dc.contributor.author Ugarte Gil, Cesar Augusto
dc.contributor.author Guerra Gronerth, Rosio I.
dc.contributor.author Lucchetti, Aldo
dc.contributor.author Grogl, Max
dc.contributor.author Gotuzzo Herencia, José Eduardo
dc.coverage.spatial Centro Médico Naval—Cirujano Mayor Santiago Tavara
dc.coverage.spatial Hospital Cayetano Heredia
dc.coverage.spatial Hospital Nacional Arzobispo Loayza
dc.date.accessioned 2023-03-23T15:49:33Z
dc.date.available 2023-03-23T15:49:33Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/20.500.12866/13272
dc.description.abstract OBJECTIVE: To assess the effectiveness and safety of hydroxychloroquine (HCQ) prophylaxis for the prevention of SARS-CoV-2 infection in healthcare workers (HCW) on duty during the COVID-19 pandemic. RESULTS: A total of 68 HCWs met the eligibility criteria were randomly allocated to receive HCQ (n = 36) or not (n = 32). There were no significant differences between groups in respects to age, gender, or medical history. Eight participants met the primary efficacy endpoint of SAR-CoV-2 infection during the study period; there was no difference in incidence of SARS-CoV-2 infections between both study arms (HCQ: 5 vs Control: 3, p = 0.538). The relative risk of SARS-CoV-2 infection in the HCQ arm was 1.69 compared to the control group (95%CI 0.41-7.11, p = 0.463); due to poor participant accrual, the resulting statistical power of the primary efficacy outcome was 11.54%. No serious adverse events occurred; however, two (2/36, 5.6%) participants no longer wished to participate in the study and withdrew consent due to recurring grade 1 and 2 adverse events. en_US
dc.language.iso eng
dc.publisher Biomed Central
dc.relation.ispartofseries BMC Research Notes
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject COVID-19 en_US
dc.subject Prophylaxis en_US
dc.subject Global health en_US
dc.subject.mesh COVID-19
dc.subject.mesh Profilaxis Antibiótica
dc.subject.mesh Salud Global
dc.title Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/s13104-023-06281-7
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.05
dc.relation.issn 1756-0500


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