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0 0.5 1 1.5 2+ Progression -100% Improvement Relative Risk Progression (b) -233% Progression (c) -225% c19hcq.com Roy-García et al. NCT04964583 HCQ RCT EARLY TREATMENT 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)
16 Apr 2022    Source   PDF   Share   Tweet
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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