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Efficacy and safety of ivermectin in patients with mild and moderate COVID-19: A randomized controlled trial

Malektojari et al., Asian Pacific Journal of Tropical Medicine, doi:10.4103/1995-7645.364007, IRCT20200506047323N6
Jan 2022  
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Small trial with 50% of patients missing without explanation. The protocol and registration show both outpatient and inpatient inclusion, with 60 patients in each group, a total of 120 patients, and enrollment completed as of July 11, 2022 Outpatient results are missing, suggesting a bias toward reporting null results.
Primary outcomes do not match between the protocol and paper.
The paper indicates a five day course of 0.2µg/kg ivermectin, however the registration and protocol indicate only a single dose - clearly specifying the number of days for other treatments, but only a single dose for ivermectin. The published protocol indicates that only the control group received lopinavir/ritonavir + interferon beta-1a, the paper is ambiguous, while the registration indicates both groups received lopinavir/ritonavir + interferon beta-1a.
The title is incorrect - "mild and moderate COVID-19". The authors more accurately state "moderate to severe COVID-19" in the conclusion. The inclusion of severe cases violates the protocol where severe cases are excluded. The registration indicates that the outcomes were measured with a questionnaire.
We are waiting for a response from the authors.
Malektojari et al., 25 Jan 2022, Randomized Controlled Trial, peer-reviewed, 7 authors, trial IRCT20200506047323N6.
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Efficacy and safety of ivermectin in patients with mild and moderate COVID-19: A randomized controlled trial
Mohammadhamed Ersi, Alireza Malektojari, Sara Ghazizadeh, Elham Brahimi, Soheil Hassanipour, Mohammad Fathalipour, Mehdi Hassaniazad
Asian Pacific Journal of Tropical Medicine, doi:10.4103/1995-7645.364007
Methods: This study was a single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design on 68 patients with COVID-19. According to the 1:1 ratio between the study groups (ivermectin group and standard treatment group), patients were randomly admitted to each intervention arm. Results: The mean age of the participants in the ivermectin group was (48.37±13.32) years. Eighteen of them were males (54.5%) and the participants in the control group had a mean age of (46.28±14.47) years, with nineteen of them being males (59.4%). As a primary outcome, after 5 days of randomization, there was no significant difference between the ivermectin group and the control group in the length of stay in the hospital (P=0.168). ICU admission (P=0.764), length of stay in ICU (P=0.622), in-hospital mortality (P=0.427), adverse drug reactions, and changes in the mean difference of laboratory data had not any significant difference between the two groups (except for urea change). In addition, the radiologic findings of the two groups of patients were not significantly different. Linear regression analysis showed that for every 10 years increase of age, 0.6 day of hospitalization duration was increased. There was no statistically significant association between other variables and clinical outcomes. Conclusions: Among adult hospitalized patients with moderate to severe COVID-19, there was no significant relationship between the administration of ivermectin single dose in a five-day course and clinical improvement, and mortality of the participants.
Conflict of interest statement The authors declare that they have no competing interests. Authors' contributions EB, MH, and MF designed the study; AM and SG recruited the subjects and followed them up; SH analyzed the data; MHE wrote the manuscript; MHE, AM and SG edited and revised the manuscript according to the journal's instructions. All authors read and approved the final manuscript. Publisher's note The Publisher of the Journal remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Late treatment
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