Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial
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)
Abstract: (2023) 16:22
Llanos‑Cuentas et al. BMC Research Notes
BMC Research Notes
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
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
Instituto de Medicina Tropical Alexander Von Humboldt, Universidad
Peruana Cayetano Heredia, Av. Honorio Delgado 430, San Martín de
Porres, 15102 Lima, Peru
School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru
Department of Infectious Diseases, Hospital Cayetano Heredia, Lima,
Centro Médico Naval Cirujano Mayor Santiago Tavara, Callao, Peru
School of Medicine, Universidad Científica del Sur, Lima, Peru
School of Medicine, Universidad Peruana de Ciencias Aplicadas, Lima,
Department of Infectious Diseases, Hospital Nacional Arzobispo Loayza,
U.S. Naval Medical Research Unit No. 6, Lima, Peru
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation. FLCCC
provide treatment protocols.