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

DOI record: { "DOI": "10.1186/s13104-023-06281-7", "ISSN": [ "1756-0500" ], "URL": "http://dx.doi.org/10.1186/s13104-023-06281-7", "abstract": "<jats:title>Abstract</jats:title><jats:sec>\n <jats:title>Objective</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>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.</jats:p>\n <jats:p><jats:italic>Trial registration:</jats:italic> ClinicalTrials.gov ID: NCT04414241. (Registered on June 4, 2020).</jats:p>\n </jats:sec>", "alternative-id": [ "6281" ], "article-number": "22", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "1 July 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "30 January 2023" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "28 February 2023" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Ethics approval and consent to participate", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "value": "The study was approved by the independent ethics committee (IEC) Transitory National Committee of Ethics in Research (CNTEI, acronym in Spanish) from Peru, as process number CNTEI-003-200. This trial was conducted in compliance with the International Conference on Harmonisation (ICH-GCP) E6 on Good Clinical Practice and the clinical trial regulations for COVID-19 (Supreme Decree No. 014-2020 SA) from the National Health Institute (INS, acronym in Spanish). All participants gave written informed consent." }, { "group": { "label": "Consent for publication", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "Not applicable." }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 4, "value": "The authors have no relevant financial or non-financial interests to disclose." } ], "author": [ { "affiliation": [], "family": "Llanos-Cuentas", "given": "Alejandro", "sequence": "first" }, { "affiliation": [], "family": "Schwalb", "given": "Alvaro", "sequence": "additional" }, { "affiliation": [], "family": "Quintana", "given": "Juan Luis", "sequence": "additional" }, { "affiliation": [], "family": "Delfin", "given": "Brian", "sequence": "additional" }, { "affiliation": [], "family": "Alvarez", "given": "Fiorela", "sequence": "additional" }, { "affiliation": [], "family": "Ugarte-Gil", "given": "César", "sequence": "additional" }, { "affiliation": [], "family": "Guerra Gronerth", "given": "Rosio I.", "sequence": "additional" }, { "affiliation": [], "family": "Lucchetti", "given": "Aldo", "sequence": "additional" }, { "affiliation": [], "family": "Grogl", "given": "Max", "sequence": "additional" }, { "affiliation": [], "family": "Gotuzzo", "given": "Eduardo", "sequence": "additional" } ], "container-title": "BMC Research Notes", "container-title-short": "BMC Res Notes", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2023, 2, 28 ] ], "date-time": "2023-02-28T03:02:34Z", "timestamp": 1677553354000 }, "deposited": { "date-parts": [ [ 2023, 2, 28 ] ], "date-time": "2023-02-28T03:06:17Z", "timestamp": 1677553577000 }, "indexed": { "date-parts": [ [ 2023, 2, 28 ] ], "date-time": "2023-02-28T05:40:05Z", "timestamp": 1677562805972 }, "is-referenced-by-count": 0, "issue": "1", "issued": { "date-parts": [ [ 2023, 2, 28 ] ] }, "journal-issue": { "issue": "1", "published-online": { "date-parts": [ [ 2023, 12 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 2, 28 ] ], "date-time": "2023-02-28T00:00:00Z", "timestamp": 1677542400000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 2, 28 ] ], "date-time": "2023-02-28T00:00:00Z", "timestamp": 1677542400000 } } ], "link": [ { "URL": "https://link.springer.com/content/pdf/10.1186/s13104-023-06281-7.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/article/10.1186/s13104-023-06281-7/fulltext.html", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/content/pdf/10.1186/s13104-023-06281-7.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1186", "published": { "date-parts": [ [ 2023, 2, 28 ] ] }, "published-online": { "date-parts": [ [ 2023, 2, 28 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "DOI": "10.1001/jama.2020.22389", "author": "MS Saag", "doi-asserted-by": "publisher", "first-page": "2161", "journal-title": "JAMA J Am Med Assoc", "key": "6281_CR1", "unstructured": "Saag MS. 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