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0 0.5 1 1.5 2+ Mortality 31% Improvement Relative Risk Ventilation 50% ICU admission 16% Hospitalization time -11% Deterioration -13% Recovery 24% post-hoc primary Recovery, day 7, cough 64% Recovery, day 7, tachypnea 76% Rezai et al. IRCT20111224008507N5 Ivermectin RCT LATE 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, IRCT20111224008507N5
16 Jun 2022    Source   PDF   Share   Tweet
RCT 609 inpatients in Iran. Reported outcomes are very different from the pre-specified outcomes []. The outpatient trial is listed separately.
From the pre-specified outcomes, all are either positive or not reported. Pre-specified outcomes:
- Reduction in persistent cough - RR 0.36 p = 0.06
- Negative RT-PCR - not reported
- Main complaints recovery time - not reported
- Mortality - RR 0.69 p = 0.36
- Side effects - reported as none (anomalous)
- Reduction in tachypnea - RR 0.24 p = 0.38
- Oxygen saturation >94% - not reported
All negative outcomes are protocol violations and are not listed in the protocol, including the novel ""relative recovery" outcome.
Authors include a researcher caught on video admitting that conclusions on ivermectin research were influenced by a funder [].
Severe cases were more frequent in the ivermectin group, 49% vs. 43%.
Dose was limited at a maximum of 30mg for 75+kg, resulting in underdosing for patients at higher risk.
Almost all patients received remdesivir, most patients received famotidine and vitamin C, and many patients received vitamin D, metformin, and zinc, limiting room for improvement.
32% of patients were lost to followup.
Authors indicate bottles were identical, but tablets were only similar.
Ivermectin was obtained from Alborz Daru Co.
risk of death, 30.8% lower, RR 0.69, p = 0.36, treatment 13 of 311 (4.2%), control 18 of 298 (6.0%), NNT 54.
risk of mechanical ventilation, 50.0% lower, RR 0.50, p = 0.07, treatment 311, control 298.
risk of ICU admission, 16.0% lower, RR 0.84, p = 0.47, treatment 311, control 298.
hospitalization time, 11.5% higher, relative time 1.11, p = 0.009, treatment mean 7.98 (±4.4) n=311, control mean 7.16 (±3.2) n=298.
deterioration, 12.7% higher, RR 1.13, p = 0.74, treatment 20 of 311 (6.4%), control 17 of 298 (5.7%).
risk of no recovery, 24.2% lower, RR 0.76, p = 0.02, treatment 311, control 298, inverted to make RR<1 favor treatment, post-hoc primary outcome.
risk of no recovery, 64.0% lower, RR 0.36, p = 0.06, treatment 5 of 145 (3.4%), control 10 of 105 (9.5%), NNT 16, day 7, cough.
risk of no recovery, 76.0% lower, RR 0.24, p = 0.38, day 7, tachypnea.
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 53.8, 29 authors, study period 19 February, 2021 - 14 August, 2021, average treatment delay 7.18 days, dosage 400μg/kg days 1-3, trial IRCT20111224008507N5.
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