Hydroxychloroquine for prophylaxis of COVID-19 in health workers: A randomized clinical trial

DOI record: { "DOI": "10.1371/journal.pone.0261980", "ISSN": [ "1932-6203" ], "URL": "http://dx.doi.org/10.1371/journal.pone.0261980", "abstract": "<jats:sec id=\"sec001\">\n<jats:title>Introduction</jats:title>\n<jats:p>Health care workers are at high risk of being infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Our aim is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) for prophylaxis of coronavirus disease 19 (COVID-19) in health personnel exposed to patients infected by SARS-CoV-2.</jats:p>\n</jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods</jats:title>\n<jats:p>Double-blind randomized, placebo-controlled single center clinical trial. Included subjects were health care workers caring for severe COVID-19 patients. Main outcome was time to symptomatic SARS-CoV-2 infection.</jats:p>\n</jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results</jats:title>\n<jats:p>127 subjects with a confirmed baseline negative RT-PCR SARS-CoV2 test were included in the trial. 62 assigned to HCQ and 65 to placebo. One subject (1.6%) in the HCQ group and 6 (9.2%) subjects in the placebo group developed COVID-19 (Log-Rank test p = 0.07). No severe COVID-19 cases were observed. The study was suspended because of a refusal to participate and losses to follow up after several trials reported lack of effectiveness of hydroxychloroquine in hospitalized patients with COVID-19.</jats:p>\n</jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion</jats:title>\n<jats:p>The effect size of hydroxychloroquine was higher than placebo for COVID-19 symptomatic infection in health personnel, although this was not statistically significant. The trial is underpowered due to the failure to complete the estimated sample size.</jats:p>\n</jats:sec>", "author": [ { "affiliation": [], "family": "Rojas-Serrano", "given": "Jorge", "sequence": "first" }, { "ORCID": "http://orcid.org/0000-0002-5032-4076", "affiliation": [], "authenticated-orcid": true, "family": "Portillo-Vásquez", "given": "Angelica Margarita", "sequence": "additional" }, { "affiliation": [], "family": "Thirion-Romero", "given": "Ireri", "sequence": "additional" }, { "affiliation": [], "family": "Vázquez-Pérez", "given": "Joel", "sequence": "additional" }, { "affiliation": [], "family": "Mejía-Nepomuceno", "given": "Fidencio", "sequence": "additional" }, { "affiliation": [], "family": "Ramírez-Venegas", "given": "Alejandra", "sequence": "additional" }, { "affiliation": [], "family": "Pérez-Kawabe", "given": "Karla Midori", "sequence": "additional" }, { "affiliation": [], "family": "Pérez-Padilla", "given": "Rogelio", "sequence": "additional" } ], "container-title": "PLOS ONE", "container-title-short": "PLoS ONE", "content-domain": { "crossmark-restriction": false, "domain": [ "www.plosone.org" ] }, "created": { "date-parts": [ [ 2022, 2, 9 ] ], "date-time": "2022-02-09T18:27:53Z", "timestamp": 1644431273000 }, "deposited": { "date-parts": [ [ 2022, 2, 9 ] ], "date-time": "2022-02-09T18:28:33Z", "timestamp": 1644431313000 }, "editor": [ { "affiliation": [], "family": "Triche", "given": "Elizabeth W", "sequence": "first" } ], "funder": [ { "DOI": "10.13039/100004339", "doi-asserted-by": "publisher", "name": "Sanofi" }, { "award": [ "FORDECYT/07SE/2020/03/31-04" ], "name": "CONACYT" } ], "indexed": { "date-parts": [ [ 2023, 8, 5 ] ], "date-time": "2023-08-05T15:29:20Z", "timestamp": 1691249360390 }, "is-referenced-by-count": 11, "issue": "2", "issued": { "date-parts": [ [ 2022, 2, 9 ] ] }, "journal-issue": { "issue": "2", "published-online": { "date-parts": [ [ 2022, 2, 9 ] ] } }, "language": "en", "license": [ { "URL": "http://creativecommons.org/licenses/by/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2022, 2, 9 ] ], "date-time": "2022-02-09T00:00:00Z", "timestamp": 1644364800000 } } ], "link": [ { "URL": "https://dx.plos.org/10.1371/journal.pone.0261980", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "340", "original-title": [], "page": "e0261980", "prefix": "10.1371", "published": { "date-parts": [ [ 2022, 2, 9 ] ] }, "published-online": { "date-parts": [ [ 2022, 2, 9 ] ] }, "publisher": "Public Library of Science (PLoS)", "reference": [ { "DOI": "10.1177/0025817220923694", "article-title": "Covid-19 and infection in health-care workers: An emerging problem", "author": "R Barranco", "doi-asserted-by": "crossref", "first-page": "65", "issue": "2", "journal-title": "Med Leg J", "key": "pone.0261980.ref001", "volume": "88", "year": "2020" }, { "article-title": "Epidemiology of and risk factors for COVID-19 infection among health care workers: A multi-centre comparative study", "author": "J Te Wei", "first-page": "1", "issue": "19", "journal-title": "Int J Environ Res Public Health", "key": "pone.0261980.ref002", "volume": "17", "year": "2020" }, { "article-title": "The experience of the health care workers of a severely hit SARS-CoV-2 referral Hospital in Italy: incidence, clinical course and modifiable risk factors for COVID-19 infection", "author": "M Colaneri", "first-page": "1", "journal-title": "J Public Health (Bangkok)", "key": "pone.0261980.ref003", "year": "2020" }, { "key": "pone.0261980.ref004", "unstructured": "COVID-19 has infected some 570,000 health workers and killed 2,500 in the Americas, PAHO Director says—PAHO/WHO | Pan American Health Organization. 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