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All Studies   Meta Analysis    Recent:   

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
Feb 2023  
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Case -69% Improvement Relative Risk HCQ  Llanos-Cuentas et al.  Prophylaxis  RCT 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) c19hcq.org Llanos-Cuentas et al., BMC Research No.., Feb 2023 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19hcq.org
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.
This PaperHCQAll
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.
Abbreviations Funding None. • fast, convenient online submission • thorough peer review by experienced researchers in your field • rapid publication on acceptance • support for research data, including large and complex data types • gold Open Access which fosters wider collaboration and increased citations maximum visibility for your research: over 100M website views per year • At BMC, research is always in progress. Learn more biomedcentral.com/submissions Ready to submit your research Ready to submit your research ? Choose BMC and benefit from: ? Choose BMC and benefit from: 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.
References
Agusti, Guillen, Ayora, Aguilera, Vidal, Efficacy and safety of hydroxychloroquine in healthcare professionals with mild SARS-CoV-2 infection: prospective, non-randomized trial, Enferm Infecc Microbiol Clin
Boulware, Pullen, Bangdiwala, Pastick, Lofgren et al., A randomized trial of hydroxychloroquine as postexposure prophylaxis for Covid-19, N Engl J Med
Casey, Beskow, Brown, Brown, Gayat et al., Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19, Lancet Respir Med, doi:10.1016/S2213-2600(22)00044-3
De, Mata, Pacheco, Gonzáles, Rovere, Enfermería y COVID-19 en el Perú
Gautret, Lagier, Parola, Hoang, Meddeb et al., Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial, Int J Antimicrob Agents
Hernandez, Roman, Pasupuleti, Barboza, White, Hydroxychloroquine or chloroquine for treatment or prophylaxis of COVID-19: a living systematic review, Ann Intern Med
Hooks, Bart, Vardeny, Westanmo, Adabag, Effects of hydroxychloroquine treatment on QT interval, Heart Rhythm
Janiaud, Axfors, Ioannidis, Hemkens, Recruitment and results reporting of COVID-19 randomized clinical trials registered in the first 100 days of the pandemic, JAMA Netw Open
Janiaud, Hemkens, Ioannidis, Challenges and lessons learned from COVID-19 trials: should we be doing clinical trials differently?, Can J Cardiol
Mercuro, Yen, Shim, Maher, Mccoy et al., Risk of QT interval prolongation associated with use of hydroxychloroquine with or without concomitant azithromycin among hospitalized patients testing positive for coronavirus disease 2019 (COVID-19), JAMA Cardiol
Naggie, Milstone, Castro, Collins, Seetha et al., Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ), bioRxiv
Neyra-León, Huancahuari-Nuñez, Díaz-Monge, Pinto, The impact of COVID-19 in the healthcare workforce in Peru, J Public Health Policy
Rajasingham, Bangdiwala, Nicol, Skipper, Pastick et al., Hydroxychloroquine as Pre-exposure prophylaxis for coronavirus disease 2019 (COVID-19) in healthcare workers: a randomized trial, Clin Infect Dis
Saag, Misguided use of hydroxychloroquine for COVID-19: the infusion of politics into science, JAMA J Am Med Assoc
Schwalb, Seas, The COVID-19 pandemic in Peru: what went wrong?, Am J Trop Med Hyg
Schwartz, Boulware, Lee, Hydroxychloroquine for COVID19: the curtains close on a comedy of errors, Lancet Reg Health Am
Xu, Cao, Lessons learnt from hydroxychloroquine/azithromycin in treatment of COVID-19, Eur Respir J, doi:10.1183/13993003.02002-2021
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