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0 0.5 1 1.5 2+ Progression -100% Improvement Relative Risk Progression (b) -233% Progression (c) -225% c19hcq.org Roy-García et al. NCT04964583 HCQ RCT EARLY TREATMENT Is early treatment with HCQ beneficial for COVID-19? Double-blind RCT 62 patients in Mexico Higher progression with treatment Roy-García et al., medRxiv, doi:10.1101/2022.04.06.22273531 Favors HCQ Favors control
Efficacy and Safety of Fixed Combination of Hydroxychloroquine with Azithromycin Versus Hydroxychloroquine and Placebo in Patients with Mild COVID-19: Randomized, double blind, Placebo controlled trial
Roy-García et al., medRxiv, doi:10.1101/2022.04.06.22273531 (Preprint), NCT04964583 (history)
Roy-García et al., Efficacy and Safety of Fixed Combination of Hydroxychloroquine with Azithromycin Versus Hydroxychloroquine and.., medRxiv, doi:10.1101/2022.04.06.22273531 (Preprint), NCT04964583
Apr 2022   Source   PDF  
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Small early terminated RCT in Mexico with 31 HCQ and 31 control patients, showing higher progression with treatment. There were no hospitalizations in the HCQ and control groups. HCQ patients were older, 38 vs. 32. There were no differences in QT segment duration and no cardiovascular complications.
The analysis presented includes data from participants that withdrew consent or received incorrect medication (5 patients for HCQ+AZ, 1 HCQ, 0 control). The HCQ+AZ arm was not blind due to the use of a different pill regimen. Results for the individual components of the progression outcome are not provided.
The dosing regimen is poor. Dosing studies and HCQ trials show that a loading dose and sufficiently high doses are important to reach therapeutic concentrations quickly [Ali, Ragonnet], and that excessive cumulative doses over time are harmful.
With the already late treatment (IQR 4-6 days) and non-weight-specific dosing, it is likely that therapeutic concentrations would not be reached early enough during the viral phase in most patients, and the continued treatment for 10 days suggests harmful tissue concentrations could be reached for some patients.
risk of progression, 100% higher, RR 2.00, p = 1.00, treatment 2 of 31 (6.5%), control 1 of 31 (3.2%), supplemental oxygen.
risk of progression, 233.3% higher, RR 3.33, p = 0.06, treatment 10 of 31 (32.3%), control 3 of 31 (9.7%), pneumonia.
risk of progression, 225.0% higher, RR 3.25, p = 0.02, treatment 13 of 31 (41.9%), control 4 of 31 (12.9%), oxygen saturation less than 90%, dyspnea, or pneumonia.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Roy-García et al., 16 Apr 2022, Double Blind Randomized Controlled Trial, Mexico, preprint, 11 authors, average treatment delay 5.0 days, dosage 200mg bid days 1-10, trial NCT04964583 (history).
Contact: ivonne3316@gmail.com, sesby14@gmail.com.
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Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.04.06.22273531; this version posted April 16, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . 1 2 3 Title: 4 Versus Hydroxychloroquine and Placebo in Patients with Mild COVID-19: 5 Randomized, double blind, Placebo controlled trial” 6 Authors 7 Ivonne A Roy-García1¶, Moises Moreno-Noguez2¶, Rodolfo Rivas-Ruiz1*, Marta 8 Zapata-Tarres 3&, Marcela Perez-Rodriguez1&, Magaly A Ortiz-Zamora4, Lourdes 9 Gabriela Navarro-Susano4, Lilia M Guzman-Rivas5, Luis Rey Garcia-Cortes6, Icela 10 Palma-Lara7, Pedro Gutierrez-Catrellón3,8, #a, #b. “Efficacy and Safety of Fixed Combination of Hydroxychloroquine with Azithromycin 11 12 13 1. Centro de Adiestramiento en Investigación Clínica, División de Investigación Clínica, Instituto Mexicano del Seguro Social, México. 14 2. Unidad de Medicina Familiar #55 Zumpango, Órgano de Operación 15 Administrativa Desconcentrada Estado de México Oriente, Instituto Mexicano 16 del Seguro Social, México. 17 3. Fundación IMSS, A.C, México 18 4. Unidad de Medicina Familiar #28, Instituto Mexicano del Seguro Social, 19 México. 20 5. Unidad de Medicina Familiar #52 Cuautitlán Izcalli, Órgano de Operación 21 Administrativa Desconcentrada Estado de México Oriente, Instituto Mexicano 22 del Seguro Social, México. 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2022.04.06.22273531; this version posted April 16, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . 23 6. Coordinación Auxiliar Médica de Investigación en Salud, Órgano de 24 Operación Administrativa Desconcentrada Regional Estado de México 25 Oriente, Instituto Mexicano del Seguro Social, México. 26 7. Centro de Investigación Translacional en Ciencias de la Salud, México 27 #a Hospital Dr. Manuel Gea González, México 28 29 30 * Corresponding author Email:rivasrodolfo@gmail.com (RR) 31 2 medRxiv preprint doi: https://doi.org/10.1101/2022.04.06.22273531; this version posted April 16, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license . 32 33 34 35 Abstract To determine the efficacy and safety of fixed combination of 36 hydroxychloroquine/azithromycin (HCQ+AZT) compared to hydroxychloroquine 37 (HCQ) alone or placebo in mild COVID-19 outpatients to avoid hospitalization. 38 Materials and methods 39 This randomized, parallel, double-blind clinical trial included male and female 40 patients aged 18 and 76 years non COVID vaccinated, who were diagnosed with 41 mild COVID-19 infection. All patients underwent liver and kidney profile test, as well 42 as a health questionnaire and clinical revision to document that they did not have 43 uncontrolled comorbidities. They were randomly assigned to one of the three 44 treatment arms: 1)..
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