Efficacy of Ivermectin in COVID-19 Patients with Mild to Moderate Disease

  1. Karamat Hussain Shah Bukhari
  2. Asma Asghar
  3. Najma Perveen
  4. Arshad Hayat
  5. Sermad Ahmad Mangat
  6. Kamil Rehman Butt
  7. Mohammad Abdullah
  8. Tehreem Fatima
  9. Ahmad Mustafa
  10. Talal Iqbal

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Abstract

Objective

To evaluate the efficacy of ivermectin (IVM) as an addition to the standard of care (SOC) treatment in COVID-19 patients with mild and moderate disease

Materials and Methods

A randomized clinical trial (Trial registration # NCT04392713 ) was carried out at Combined Military Hospital Lahore from March 15, 2020, to June 15, 2020. Eighty-six patients with reverse transcriptase-polymerase chain reaction (RT-PCR) proven SARS-CoV-2 infection completed the trial protocol. Patients were stratified via the lottery method into two groups. Group A was administered standard of care (SOC) treatment as per existing hospital guidelines whereas group B was given ivermectin (single dose of 12 milligrams) along with SOC treatment. PCR was repeated at 72 hours, 7 th day, and at 14 th day of admission for both the groups and the point at which the PCR became negative was noted. Complete blood counts, liver function tests and renal function tests were done at recruitment, 7 th day, and 14 th day. The primary outcome was the viral clearance, measured as days to achieve PCR negativity. The secondary outcome was the development of any adverse side effects pertinent to ivermectin or derangement in baseline laboratory parameters.

Results

In group A, 36 (80%) participants were males, and 9 (20%) were females, whereas in group B, 37 (90.2%) were males and 4 (9.8%) were females. Mean age was 39.0± 12.6 and 42.2 ± 12.0 years for groups A and B, respectively (p= 0.394). There was early viral clearance in group B as compared to group A (p=0.001). No adverse reaction or derangements in laboratory parameters was noted in the intervention arm during the trial period.

Conclusion

In the intervention arm, early viral clearance was observed and no side effects were documented. Therefore ivermectin is a potential addition to the standard care of treatment in COVID-19 patients.

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  1. ScreenIT

    SciScore for 10.1101/2021.02.02.21250840: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: This study is a randomized controlled clinical trial (Trial Registration # NCT04392713) carried out from 15th March to 15th June 2020 after approval by the institutional review board and was conducted in compliance with the principles laid down in the Declaration of Helsinki.
    Consent: Patients were considered eligible if they were able to consent for trial, stated their willingness to comply with all study procedures, agreed for admission for the trial period (14 days), and those able to take oral medication.
    RandomizationThis study is a randomized controlled clinical trial (Trial Registration # NCT04392713) carried out from 15th March to 15th June 2020 after approval by the institutional review board and was conducted in compliance with the principles laid down in the Declaration of Helsinki.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableAll females of childbearing age were to undergo a pregnancy test and a positive test would mean that they would be excluded.

    Table 2: Resources

    No key resources detected.

    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:
    There were however certain limitations and shortcomings of the study. The duration and severity of individual symptoms and time of resolution of these symptoms were not studied. Most of the patients were lost to follow up after the trial period concluded and very few could be traced back to assess for any potential adverse reaction that may have occurred due to treatment with ivermectin, hence prolonged safety of drug could not be established. However, no side effects were noted during the trial period and ivermectin was well tolerated. Majorly our participants were males and the results may not be generalizable to both genders. Although our research gives an indicator to a very strong potential candidate for the treatment of COVID-19, all possible confounders can never be reliably ruled out. However, as the cases of COVID-19 surge, we have a reason to believe that even this initial information could be of importance for clinicians and researchers. This drug has an established therapeutic benefit and should be considered for testing in other setups. In continuation of this trial, enrollment needs to be extended to patients with severe symptoms of COVID-19, to reduce the need for treatment escalation.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04392713RecruitingEfficacy of Ivermectin in COVID-19

    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 scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.02.02.21250840 on medRxiv