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All Studies   Meta Analysis   Recent:  
0 0.5 1 1.5 2+ Progression -100% Improvement Relative Risk Progression (b) -233% Progression (c) -225% HCQ  Roy-García et al.  EARLY TREATMENT  DB RCT Is early treatment with HCQ beneficial for COVID-19? Double-blind RCT 62 patients in Mexico (January - June 2021) Higher progression with treatment c19hcq.org Roy-García et al., medRxiv, April 2022 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, NCT04964583
Apr 2022  
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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, study period January 2021 - June 2021, 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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This PaperHCQAll
“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”
Ivonne A Roy-García, Moises Moreno-Noguez, Rodolfo Rivas-Ruiz, Marta Zapata-Tarres, Marcela Perez-Rodriguez, Magaly A Ortiz-Zamora, Lourdes Gabriela Navarro-Susano, Lilia M Guzman-Rivas, Luis Rey Garcia-Cortes, Icela Palma-Lara, Pedro Gutierrez-Catrellón
doi:10.1101/2022.04.06.22273531
To determine the efficacy and safety of fixed combination of hydroxychloroquine/azithromycin (HCQ+AZT) compared to hydroxychloroquine (HCQ) alone or placebo in mild COVID-19 outpatients to avoid hospitalization. Materials and methods This randomized, parallel, double-blind clinical trial included male and female patients aged 18 and 76 years non COVID vaccinated, who were diagnosed with mild COVID-19 infection. All patients underwent liver and kidney profile test, as well as a health questionnaire and clinical revision to document that they did not have uncontrolled comorbidities. They were randomly assigned to one of the three treatment arms: 1) hydroxychloroquine with azithromycin 200 mg/250 mg every 12 hours for five days followed by hydroxychloroquine 200 mg every 12 hours for 5 days; 2) hydroxychloroquine 200 mg every 12 hours for ten days; or 3) placebo every 12 hours for ten days. The primary outcome of the study was hospitalization, while the secondary outcomes were disease progression, pneumonia, use of supplemental oxygen, and adverse events. This study was registered in clinicaltrials.gov with the NCT number of 04964583. Results A total of 92 participants were randomized. Of whom, 30 received HCQ+AZT, 31 received HCQ, and 31 received placebo. The median age was 37 years, 27.2% of the participants had comorbidities, and the global incidence of hospitalization was .
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