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All Studies   Meta Analysis   Recent: 
0 0.5 1 1.5 2+ Mortality 16% Improvement Relative Risk Hospitalization -28% c19hcq.org Cavalcanti et al. HCQ for COVID-19 RCT LATE TREATMENT Favors HCQ Favors control
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19
Cavalcanti et al., NEJM, July 23, 2020, doi:10.1056/NEJMoa2019014
23 Jul 2020    Source   PDF   Share   Tweet
Late stage RCT of 667 hospitalized patients with up to 14 days of symptoms at enrollment and receiving up to 4 liters per minute supplemental oxygen, not finding a significant effect after 15 days.
Authors note: "the trial cannot definitively rule out either a substantial benefit of the trial drugs or a substantial harm", sample sizes are too small.
The paper uses the terms mild and moderate, however all patients had serious enough disease to be hospitalized, and 14% were actually randomized in the ICU.
The trial had significant protocol deviations and unusually low medication adherence. Randomization resulted in 64.3% male patients (HCQ) vs. 54.2% (control) which may significantly affect results due to the much higher risk for male patients.
Authors note: "our aim was to exclude patients already receiving longer and potentially therapeutic doses of the study treatments" in explanation for why the study protocol was changed to exclude patients with previous use of the medications >24hrs. Analyzing these patients rather than excluding them may have revealed effectiveness with early use as shown in other studies.
The trial initially required enrollment within 48 hours of admission and was changed to remove this requirement, this change is likely to reduce effectiveness because enrollment was moved later, compared to the time the disease became serious enough for hospitalization. Total HCQ dosage 5.6g.
A correction for 17 errors has been published: [nejm.org]
Although the 16% lower mortality is not statistically significant, it is consistent with the significant 22% lower mortality [18‑27%] from meta analysis of the 228 mortality results to date.
risk of death, 16.0% lower, RR 0.84, p = 0.77, treatment 8 of 331 (2.4%), control 5 of 173 (2.9%), NNT 211, HCQ+HCQ/AZ.
risk of hospitalization, 28.0% higher, RR 1.28, p = 0.30, treatment 331, control 173, HCQ+HCQ/AZ.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cavalcanti et al., 23 Jul 2020, Randomized Controlled Trial, Brazil, peer-reviewed, baseline oxygen required 41.8%, 14 authors, average treatment delay 7.0 days.
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