Efficacy and Safety of Indomethacin in Covid -19 patients

  1. Rajan Ravichandran
  2. Prassana Purna
  3. Sivakumar Vijayaragavan
  4. Ravi Teja Kalavakollu
  5. Shilpa Gaidhane
  6. Ramarathnam Krishna Kumar

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Abstract

Abstract Background Indomethacin, a well-known non-steroidal anti-inflammatory drug (NSAID), has in addition broad spectrum anti-viral activity in the laboratory including on SARS-Cov-2 virus. This trial is to observe the likelihood of efficacy and safety of Indomethacin in treating RT-PCR positive Covid patients Materials and Methods The study was done in two groups. In the first group of the study, where mild and moderate patients were involved, Propensity Score Matching was used as a methodology to compare Indomethacin and paracetamol based treatments in addition to the standard protocol for treating covid-19 patients.. Blood chemistry was collected before and after the treatment. The patients were monitored every day for clinical parameters. In this part, a patient developing hypoxia was the end point. In the second group, severe patients admitted with hypoxia were treated with Indomethacin in addition to Remdesivir, and the end point was the requirement of mechanical ventilation/admission to ICU. Results It was observed that patients treated with Indomethacin had a reduction in the number of days to become afebrile, reduction in cough and myalgia by half compared to the paracetamol set. Only one out of 72 patients in the Indomethacin arm of the first group required supplementary oxygen while 28 of the 72 patients required supplementary oxygen in the paracetamol arm. No one in the second group deteriorated enough to require mechanical ventilation. There wea no evidence of adverse reaction to indomethacin or deterioration of renal or liver function. Conclusion Indomethacin, along with standard care, seems to provide faster symptomatic relief and prevent progression of pneumonia in Covid-19 patients. It should be considered to replace paracetamol when there is no contraindication for its use.

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  1. ScreenIT

    SciScore for 10.1101/2020.12.14.20245266: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Nellore, Andhra Pradesh, India, and Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India) patients who tested RT-PCR positive for Covid-19 were recruited for an open labelled single arm study for the efficacy and safety of Indomethacin after obtaining Ethics Committee clearance and consent from the patients.
    Consent: Nellore, Andhra Pradesh, India, and Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India) patients who tested RT-PCR positive for Covid-19 were recruited for an open labelled single arm study for the efficacy and safety of Indomethacin after obtaining Ethics Committee clearance and consent from the patients.
    RandomizationThough technically it is not a double arm randomized clinical trial, it is now accepted that Propensity Score Matching [17] mimics Randomized Control Trial (RCT).
    Blindingnot detected.
    Power AnalysisPost-hoc calculations based on the actual result gave a marginal power of 0.99.
    Sex as a biological variablenot detected.

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

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

    IdentifierStatusTitle
    ISRCTN11970082NANA

    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.

    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 10.1101/2020.12.14.20245266 on medRxiv