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
et al., medRxiv, doi:10.1101/2022.04.06.22273531 (Preprint), NCT04964583 (history)
, Efficacy and Safety of Fixed Combination of Hydroxychloroquine with Azithromycin Versus Hydroxychloroquine and.., medRxiv, doi:10.1101/2022.04.06.22273531 (Preprint), NCT04964583
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.
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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.
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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.
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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.
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| 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.
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 .
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Title:
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Versus Hydroxychloroquine and Placebo in Patients with Mild COVID-19:
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Randomized, double blind, Placebo controlled trial”
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Authors
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Ivonne A Roy-García1¶, Moises Moreno-Noguez2¶, Rodolfo Rivas-Ruiz1*, Marta
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Zapata-Tarres 3&, Marcela Perez-Rodriguez1&, Magaly A Ortiz-Zamora4, Lourdes
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Gabriela Navarro-Susano4, Lilia M Guzman-Rivas5, Luis Rey Garcia-Cortes6, Icela
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Palma-Lara7, Pedro Gutierrez-Catrellón3,8, #a, #b.
“Efficacy and Safety of Fixed Combination of Hydroxychloroquine with Azithromycin
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1. Centro de Adiestramiento en Investigación Clínica, División de Investigación
Clínica, Instituto Mexicano del Seguro Social, México.
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2. Unidad de Medicina Familiar #55 Zumpango, Órgano de Operación
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Administrativa Desconcentrada Estado de México Oriente, Instituto Mexicano
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del Seguro Social, México.
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3. Fundación IMSS, A.C, México
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4. Unidad de Medicina Familiar #28, Instituto Mexicano del Seguro Social,
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México.
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5. Unidad de Medicina Familiar #52 Cuautitlán Izcalli, Órgano de Operación
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Administrativa Desconcentrada Estado de México Oriente, Instituto Mexicano
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del Seguro Social, México.
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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 .
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6. Coordinación Auxiliar Médica de Investigación en Salud, Órgano de
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Operación Administrativa Desconcentrada Regional Estado de México
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Oriente, Instituto Mexicano del Seguro Social, México.
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7. Centro de Investigación Translacional en Ciencias de la Salud, México
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#a Hospital Dr. Manuel Gea González, México
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* Corresponding author
Email:rivasrodolfo@gmail.com (RR)
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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 .
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Abstract
To
determine
the
efficacy
and
safety
of
fixed
combination
of
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hydroxychloroquine/azithromycin (HCQ+AZT) compared to hydroxychloroquine
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(HCQ) alone or placebo in mild COVID-19 outpatients to avoid hospitalization.
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Materials and methods
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This randomized, parallel, double-blind clinical trial included male and female
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patients aged 18 and 76 years non COVID vaccinated, who were diagnosed with
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mild COVID-19 infection. All patients underwent liver and kidney profile test, as well
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as a health questionnaire and clinical revision to document that they did not have
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uncontrolled comorbidities. They were randomly assigned to one of the three
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treatment arms: 1)..
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