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0 0.5 1 1.5 2+ Mortality -5% Improvement Relative Risk ICU admission -9% Hospitalization -36% Recovery -2% post-hoc primary Recovery, cough 13% Recovery, tachypnea 17% Viral clearance -23% c19ivm.org Rezai et al. IRCT20111224008507N4 Ivermectin RCT EARLY Favors ivermectin Favors control
Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomized, Double-Blinded, Placebo-Controlled Clinical Trials
Rezai et al., Frontiers in Medicine, doi:10.3389/fmed.2022.919708, IRCT20111224008507N4
16 Jun 2022    Source   PDF   Share   Tweet
RCT 549 low risk outpatients in Iran. Reported outcomes are very different from the pre-specified outcomes [irct.ir]. The inpatient trial is listed separately.
The pre-specified primary clinical outcome was not reported. The reported components of this outcome are both positive.
Pre-specified outcomes (3 not reported) [irct.ir]:
- reduction in persistent cough and tachypnea and O2 saturation above 94% - not reported
- negative PCR - reported
- main complaints recovery time - not reported (only individual symptoms)
- hospitalization - reported
- time to hospitalization - not reported
- mortality - reported
- side effects - reported in only one patient (anomalous)
A new outcome "relative recovery" is reported but not mentioned in the trial registration. The reported percentages and RR do not match.
Authors include a researcher caught on video admitting that conclusions on ivermectin research were influenced by a funder [c19ivermectin.com].
Most/many patients were also treated with famotidine, vitamin C, vitamin D, and zinc, limiting room for improvement.
Authors indicate bottles were identical, but tablets were only similar.
Ivermectin was obtained from Alborz Daru Co.
risk of death, 4.9% higher, RR 1.05, p = 1.00, treatment 1 of 268 (0.4%), control 1 of 281 (0.4%).
risk of ICU admission, 9.0% higher, RR 1.09, p = 0.95, treatment 268, control 281.
risk of hospitalization, 36.0% higher, RR 1.36, p = 0.41, treatment 268, control 281.
risk of no recovery, 2.0% higher, RR 1.02, p = 0.49, treatment 268, control 281, inverted to make RR<1 favor treatment, post-hoc primary outcome.
risk of no recovery, 13.2% lower, RR 0.87, p = 0.09, treatment mean 3.87 (±0.18) n=268, control mean 4.46 (±0.18) n=281, cough.
risk of no recovery, 16.7% lower, RR 0.83, p = 0.81, treatment mean 2.5 (±0.51) n=268, control mean 3.0 (±0.92) n=281, tachypnea.
risk of no viral clearance, 23.5% higher, RR 1.23, p = 0.16, treatment 268, control 281, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
This study is excluded in the after exclusion results of meta analysis: multiple critical issues, see study page.
Rezai et al., 16 Jun 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, peer-reviewed, mean age 35.5, 29 authors, study period 19 February, 2021 - 30 August, 2021, dosage 400μg/kg days 1-3, trial IRCT20111224008507N4.
Contact: drmsrezaii@yahoo.com.
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