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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% Ivermectin  Rezai et al.  EARLY TREATMENT  DB RCT Is early treatment with ivermectin beneficial for COVID-19? Double-blind RCT 549 patients in Iran (February - August 2021) Multiple critical issues, see analysis Rezai et al., Frontiers in Medicine, Jun 2022 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
Jun 2022  
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RCT 549 low risk outpatients in Iran. Reported outcomes are very different from the pre-specified outcomes 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)
- 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
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.
This is the 38th of 46 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000014.
This is the 87th of 99 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 2 sextillion).
This study is excluded in the after exclusion results of meta analysis: multiple critical issues, see study page.
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
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.
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Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomized, Double-Blinded, Placebo-Controlled Clinical Trials
Mohammad Sadegh Rezai, Fatemeh Ahangarkani, Andrew Hill, Leah Ellis, Manya Mirchandani, Alireza Davoudi, Gohar Eslami, Fatemeh Roozbeh, Farhang Babamahmoodi, Nima Rouhani, Ahmad Alikhani, Narges Najafi, Roya Ghasemian, Hossein Mehravaran, Azin Hajialibeig, Mohammad Reza Navaeifar, Leila Shahbaznejad, Golnar Rahimzadeh, Majid Saeedi, Reza Alizadeh-Navai, Mahmood Moosazadeh, Shahab Saeedi, Seyedeh-Kiana Razavi-Amoli, Shaghayegh Rezai, Fereshteh Rostami-Maskopaee, Fatemeh Hosseinzadeh, Faezeh Sadat Movahedi, John S Markowitz, Reza Valadan
Frontiers in Medicine, doi:10.3389/fmed.2022.919708
Background: Ivermectin which was widely considered as a potential treatment for COVID-19, showed uncertain clinical benefit in many clinical trials. Performing largescale clinical trials to evaluate the effectiveness of this drug in the midst of the pandemic, while difficult, has been urgently needed. Methods: We performed two large multicenter randomized, double-blind, placebocontrolled clinical trials evaluating the effectiveness of ivermectin in treating inpatients and outpatients with COVID-19 infection. The intervention group received ivermectin, 0.4mg/kg of body weight per day for 3 days. In the control group, placebo tablets were used for 3 days. Results: Data for 609 inpatients and 549 outpatients were analyzed. In hospitalized patients, complete recovery was significantly higher in the ivermectin group (37%) compared to placebo group (28%; RR, 1.32 [95% CI, 1.04-1.66]; p-value = 0.02). On the other hand, the length of hospital stay was significantly longer in the ivermectin group with a mean of 7.98 ± 4.4 days compared to the placebo receiving group with a mean of 7.16 ± 3.2 days (RR, 0.80 [95% CI, 0.15-1.45]; p-value = 0.02). In outpatients, the
ETHICS STATEMENT The studies involving human participants were reviewed and approved by the Ethics Committee of Mazandaran University of Medical Sciences (IR.MAZUMS.REC.1399.915 and IR.MAZUMS.REC.1399.869) and by the Iranian Registry of Clinical Trials identifier (IRCT20111224008507N5 and IRCT20111224008507N4). Written informed consent to participate in this study was provided by the participants or their legal guardian/next of kin. AUTHOR CONTRIBUTIONS MR contributed to the conception or design of the work. MR, FA, AHi, LE, and MMi contributed to the drafting and statistical analysis of the manuscript. All authors contributed toward the acquisition, analysis, or interpretation of data, critical revision of the manuscript, review and approval of the final version of the manuscript. SUPPLEMENTARY MATERIAL The Supplementary Material for this article can be found online at: 2022.919708/full#supplementary-material Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's Note: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not..
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