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0 0.5 1 1.5 2+ Case -69% Improvement Relative Risk c19hcq.org Llanos-Cuentas et al. NCT04414241 HCQ RCT PrEP Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? RCT 68 patients in Peru (July - November 2020) More cases with HCQ (not stat. sig., p=0.46) Llanos-Cuentas et al., BMC Research Notes, doi:10.1186/s13104-023-06281-7 Favors HCQ Favors control
Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial
Llanos-Cuentas et al., BMC Research Notes, doi:10.1186/s13104-023-06281-7, NCT04414241 (history)
Llanos-Cuentas et al., Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3,.., BMC Research Notes, doi:10.1186/s13104-023-06281-7, NCT04414241
Feb 2023   Source   PDF  
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Early terminated healthcare worker PrEP RCT with only 68 patients and 8 cases, showing no significant difference with HCQ. No information on symptoms per group, case severity, or the timing of cases is provided.
risk of case, 69.0% higher, RR 1.69, p = 0.46, treatment 5 of 36 (13.9%), control 3 of 32 (9.4%), adjusted per study.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Llanos-Cuentas et al., 28 Feb 2023, Randomized Controlled Trial, Peru, peer-reviewed, mean age 39.2, 10 authors, study period July 2020 - November 2020, trial NCT04414241 (history).
Contact: alejandro.llanos.c@upch.pe.
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Abstract: (2023) 16:22 Llanos‑Cuentas et al. BMC Research Notes https://doi.org/10.1186/s13104-023-06281-7 BMC Research Notes Open Access RESEARCH NOTE Hydroxychloroquine to prevent SARS‑CoV‑2 infection among healthcare workers: early termination of a phase 3, randomised, open‑label, controlled clinical trial Alejandro Llanos‑Cuentas1*, Alvaro Schwalb1, Juan Luis Quintana2, Brian Delfin3, Fiorela Alvarez1, César Ugarte‑Gil1,2, Rosio I. Guerra Gronerth4,5, Aldo Lucchetti6,7, Max Grogl8 and Eduardo Gotuzzo1 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 inci‑ dence of SARS-CoV-2 infections between both study arms (HCQ: 5 vs Control: 3, p = 0.538). The relative risk of SARSCoV-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. Trial registration: ClinicalTrials.gov ID: NCT04414241. (Registered on June 4, 2020). Keywords COVID-19, Prophylaxis, Global health *Correspondence: Alejandro Llanos‑Cuentas alejandro.llanos.c@upch.pe 1 Instituto de Medicina Tropical Alexander Von Humboldt, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, San Martín de Porres, 15102 Lima, Peru 2 School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru 3 Department of Infectious Diseases, Hospital Cayetano Heredia, Lima, Peru 4 Centro Médico Naval Cirujano Mayor Santiago Tavara, Callao, Peru 5 School of Medicine, Universidad Científica del Sur, Lima, Peru 6 School of Medicine, Universidad Peruana de Ciencias Aplicadas, Lima, Peru 7 Department of Infectious Diseases, Hospital Nacional Arzobispo Loayza, Lima, Peru 8 U.S. Naval Medical Research Unit No. 6, Lima, Peru
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