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.NCT04964583
Roy-García et al., 4/16/2022, Double Blind Randomized Controlled Trial, Mexico, North America, preprint, 11 authors, average treatment delay 5.0 days, dosage 200mg bid days 1-10, trial NCT04964583