Evaluation of Ivermectin as a Potential Treatment for Mild to Moderate COVID-19: A Double-Blind Randomized Placebo Controlled Trial in Eastern India

Abstract

Background: There has been a growing interest in ivermectin ever since it was reported to have an in-vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This trial was conducted to test the efficacy of ivermectin in mild and moderate coronavirus disease 19 (COVID-19). Methods: A double blind, parallel, randomised, placebo-controlled trial conducted among adult COVID-19 patients with mild to moderate disease severity on admission in a COVID dedicated tertiary healthcare of eastern India. Enrolment was done between 1st August and 31st October 2020. On day 1 and 2 post enrolment, patients in the intervention arm received ivermectin 12 mg while the patients in the non-interventional arm received placebo tablets. Results: About one-fourth (23.6%) of the patients in the intervention arm and one-third (31.6%) in the placebo arm were tested reverse transcriptase polymerase chain reaction (RTPCR) negative for SARS-CoV-2 on 6th day. Although this difference was found to be statistically insignificant [rate ratio (RR): 0.8; 95% confidence interval (CI): 0.4-1.4; p=0.348]. All patients in the ivermectin group were successfully discharged. In comparison the same for the placebo group was observed to be 93%. This difference was found to be statistically significant (RR: 1.1; 95% CI; 1.0-1.2; p=0.045). Conclusions: Inclusion of ivermectin in treatment regimen of mild to moderate COVID-19 patients could not be said with certainty based on our study results as it had shown only marginal benefit in successful discharge from the hospital with no other observed benefits.

An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment

“…However, other studies did not report statistically significant differences in mortality ( Ravikirti and Pattadar, 2021 ), length of hospitalization ( Abdulamir et al, 2021a ) and clinical endpoints, disease progression, recovery, the occurrence of symptoms ( Okumuş et al, 2021 ). The study authors did not recommend the routine use of ivermectin in COVID-19 patients, limiting its use to a clinical trial.…”

Role of Ivermectin in Patients Hospitalized with COVID-19: A Systematic Review of Literature

“…Just over a third of trials exposed the clinical group to another medicine (excluding those in the standard of care) such as doxycycline, azithromycin, etc. Mortality was noted across eight different reports, and in almost all of them death occurrence was more prominent in the control arm [23][24][25][26][27][28][29]. The only study whose findings were not consistent with the rest is the retrospective cohort in Peru by Soto-Beccerra et al [22] which found a higher mortality rate in the interventional group.…”

Meta-Analyses Do Not Establish Improved Mortality With Ivermectin Use in COVID-19

“…In their description of the study by Ravikirti et al, mortality was described as "improved" with ivermectin compared with controls "0% versus 6.9%, P 5 0.019." 1,16 However, there was no statistical difference in mortality (0/55 vs. 4/57, Fisher exact P value 5 0.12). A mortality benefit with ivermectin in severely ill patients was stated to be "of borderline statistical significance, 0% (0/11) versus 27.3% (6/22), P 5 0.052" in the description of Hashim's study.…”