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

{ 'indexed': {'date-parts': [[2023, 2, 28]], 'date-time': '2023-02-28T05:40:05Z', 'timestamp': 1677562805972}, 'reference-count': 18, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2023, 2, 28]], 'date-time': '2023-02-28T00:00:00Z', 'timestamp': 1677542400000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2023, 2, 28]], 'date-time': '2023-02-28T00:00:00Z', 'timestamp': 1677542400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, '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\u2009=\u200936) or not (n\u2009=\u200932). 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\u2009=\u20090.538). 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\u2009=\u20090.463); 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>', 'DOI': '10.1186/s13104-023-06281-7', 'type': 'journal-article', 'created': {'date-parts': [[2023, 2, 28]], 'date-time': '2023-02-28T03:02:34Z', 'timestamp': 1677553354000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination ' 'of a phase 3, randomised, open-label, controlled clinical trial', 'prefix': '10.1186', 'volume': '16', 'author': [ {'given': 'Alejandro', 'family': 'Llanos-Cuentas', 'sequence': 'first', 'affiliation': []}, {'given': 'Alvaro', 'family': 'Schwalb', 'sequence': 'additional', 'affiliation': []}, {'given': 'Juan Luis', 'family': 'Quintana', 'sequence': 'additional', 'affiliation': []}, {'given': 'Brian', 'family': 'Delfin', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fiorela', 'family': 'Alvarez', 'sequence': 'additional', 'affiliation': []}, {'given': 'César', 'family': 'Ugarte-Gil', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rosio I.', 'family': 'Guerra Gronerth', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aldo', 'family': 'Lucchetti', 'sequence': 'additional', 'affiliation': []}, {'given': 'Max', 'family': 'Grogl', 'sequence': 'additional', 'affiliation': []}, {'given': 'Eduardo', 'family': 'Gotuzzo', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2023, 2, 28]]}, 'reference': [ { 'key': '6281_CR1', 'doi-asserted-by': 'publisher', 'first-page': '2161', 'DOI': '10.1001/jama.2020.22389', 'volume': '324', 'author': 'MS Saag', 'year': '2020', 'unstructured': 'Saag MS. 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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.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'The authors have no relevant financial or non-financial interests to disclose.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '22'}