Rezai: Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomized, Double-Blinded, Placebo-Controlled Clinical Trials

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

Rezai et al., Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomized,.., Frontiers in Medicine, doi:10.3389/fmed.2022.919708, IRCT20111224008507N5

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RCT 609 inpatients in Iran. Reported outcomes are very different from the pre-specified outcomes [irct.ir]. 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 [c19ivermectin.com].

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. This study is excluded in the after exclusion results of meta analysis: multiple critical issues, see study page.

1. c19ivermectin.com, https://c19ivermectin.com/lawrieletter.html.

2. irct.ir, https://www.irct.ir/trial/54402.

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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

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.

Contact: drmsrezaii@yahoo.com.

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Abstract: CLINICAL TRIAL published: 16 June 2022 doi: 10.3389/fmed.2022.919708 Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomized, Double-Blinded, Placebo-Controlled Clinical Trials Edited by: Mohammad Yousef Alikhani, Hamadan University of Medical Sciences, Iran Reviewed by: Amir Khodavirdipour, University of Tabriz, Iran Piyush Baindara, University of Missouri, United States *Correspondence: Mohammad Sadegh Rezai drmsrezaii@yahoo.com Specialty section: This article was submitted to Infectious Diseases – Surveillance, Prevention and Treatment, a section of the journal Frontiers in Medicine Received: 13 April 2022 Accepted: 30 May 2022 Published: 16 June 2022 Citation: Rezai MS, Ahangarkani F, Hill A, Ellis L, Mirchandani M, Davoudi A, Eslami G, Roozbeh F, Babamahmoodi F, Rouhani N, Alikhani A, Najafi N, Ghasemian R, Mehravaran H, Hajialibeig A, Navaeifar MR, Shahbaznejad L, Rahimzadeh G, Saeedi M, Alizadeh-Navai R, Moosazadeh M, Saeedi S, Razavi-Amoli S-K, Rezai S, Rostami-Maskopaee F, Hosseinzadeh F, Movahedi FS, Markowitz JS and Valadan R (2022) Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomized, Double-Blinded, Placebo-Controlled Clinical Trials. Front. Med. 9:919708. doi: 10.3389/fmed.2022.919708 Frontiers in Medicine | www.frontiersin.org Mohammad Sadegh Rezai 1* , Fatemeh Ahangarkani 2 , Andrew Hill 3 , Leah Ellis 4 , Manya Mirchandani 4 , Alireza Davoudi 2 , Gohar Eslami 5 , Fatemeh Roozbeh 6 , Farhang Babamahmoodi 2 , Nima Rouhani 2 , Ahmad Alikhani 2 , Narges Najafi 2 , Roya Ghasemian 2 , Hossein Mehravaran 7 , Azin Hajialibeig 1 , Mohammad Reza Navaeifar 1 , Leila Shahbaznejad 1 , Golnar Rahimzadeh 1 , Majid Saeedi 8 , Reza Alizadeh-Navai 6 , Mahmood Moosazadeh 6 , Shahab Saeedi 1 , Seyedeh-Kiana Razavi-Amoli 9 , Shaghayegh Rezai 10 , Fereshteh Rostami-Maskopaee 1 , Fatemeh Hosseinzadeh 1 , Faezeh Sadat Movahedi 9 , John S. Markowitz 11 and Reza Valadan 12 1 Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran, 2 Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran, 3 Department of Pharmacology and Therapeutics, Liverpool University, Liverpool, United Kingdom, 4 Faculty of Medicine, School of Public Health, Imperial College London, London, United Kingdom, 5 Department of Clinical Pharmacy, Faculty of Pharmacy, Cardiovascular Research Center, Mazandaran University of Medical Sciences, Sari, Iran, 6 Gastrointestinal Cancer Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran, 7 Department of Internal Medicine, Pulmonary and Critical Care Division, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran, 8 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran, 9 Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran, 10 Department of Microbiology and Virology, Mashhad University of Medical Sciences, Mashhad, Iran, 11 Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics and Precision Medicine, University of Florida, Gainesville, FL, United States, 12 Department of Immunology and Molecular and Cell Biology Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari,..

Late treatment
is less effective

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