Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial
Alejandro Llanos-Cuentas, Alvaro Schwalb, Juan Luis Quintana, Brian Delfin, Fiorela Alvarez, César Ugarte-Gil, Rosio I Guerra Gronerth, Aldo Lucchetti, Max Grogl, Eduardo Gotuzzo
BMC Research Notes, doi:10.1186/s13104-023-06281-7
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.
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Declarations Ethics approval and consent to participate 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.
Consent for publication Not applicable.
Competing interests The authors have no relevant financial or non-financial interests to disclose.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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