Evaluation of Ivermectin as a Potential Treatment for Mild to Moderate COVID-19: A Double-Blind Randomized Placebo Controlled Trial in Eastern India
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
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.
Article activity feed
-
-
SciScore for 10.1101/2021.01.05.21249310: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Ethical clearance was obtained from the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), Patna.
Consent: The exclusion criteria were: known allergy to or adverse drug reaction with Ivermectin; unwillingness or inability to provide consent to participate in the study; prior use of ivermectin during the course of this illness; pregnancy and lactation.Randomization After obtaining informed consent, they were randomly assigned to either group A or group B. Blinding The study design was double blind randomized placebo-controlled trial. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
… SciScore for 10.1101/2021.01.05.21249310: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Ethical clearance was obtained from the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), Patna.
Consent: The exclusion criteria were: known allergy to or adverse drug reaction with Ivermectin; unwillingness or inability to provide consent to participate in the study; prior use of ivermectin during the course of this illness; pregnancy and lactation.Randomization After obtaining informed consent, they were randomly assigned to either group A or group B. Blinding The study design was double blind randomized placebo-controlled trial. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Secondary outcomes: Statistical analysis was done using IBM SPSS (Chicago, USA) software, version-22. SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The findings of this trial should be interpreted with consideration to certain limitations. As mentioned above, a conclusive repeat RT-PCR report could not be obtained in 32.1% of the patients. Moreover, as serial RT-PCR tests were not done, the median time to viral clearance in the two groups could not be ascertained. As only mild and moderate cases were included, it cannot be said whether the benefit in survival seen with ivermectin can also be seen in severe cases. Similarly, it cannot be said on the basis of this study whether or not using higher doses of ivermectin or combining it with other drugs like doxycycline would offer any additional benefit. Similar but larger studies may be able to give a more definitive answer, especially in relation to the other secondary outcome measures.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
-
