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Review 2: "Use of Indomethacin for mild and moderate Covid -19 patients. A Randomized Control Trial"

This preprint evaluates the clinical efficacy of indomethacin for mild and moderate COVID-19, and finds that patients treated with indomethacin experienced oxygen desaturation less frequently with more rapid recovery times. Reviewers deemed the results compelling and reliable.

Published onFeb 01, 2022
Review 2: "Use of Indomethacin for mild and moderate Covid -19 patients. A Randomized Control Trial"
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key-enterThis Pub is a Review of
Indomethacin Use for Mild & Moderate hospitalised Covid-19 patients: An open label randomized clinical trial
Description

ABSTRACTIntroductionIndomethacin, a non-steroidal anti-inflammatory drug (NSAID), has been presented as a broad-spectrum antiviral agent. This randomised clinical trial in a hospital setting evaluated the efficacy and safety of this drug in RT-PCR-positive coronavirus disease 2019 (COVID-19) patients.Materials & MethodsA total of 210 RT-PCR-positive COVID-19 patients, who provided consent were allotted, to control or case arm, based on block randomisation. The control arm received standard of care comprising paracetamol, ivermectin, and other adjuvant therapies. The patients in the case arm received indomethacin instead of paracetamol, with other medications retained. The primary endpoint was the development of hypoxia/desaturation with SpO2 ≤ 93, while time to become afebrile and time for cough and myalgia resolution were the secondary endpoints.ResultsThe results of 210 patients were available, with 103 and 107 patients in the indomethacin and paracetamol arms, respectively. We monitored patient profiles along with everyday clinical parameters. Blood chemistry at the time of admission and discharge was assessed.As no one in either of the arms required high-flow oxygen, desaturation with SpO2 level of 93 and below was an important goal. In the indomethacin group, none of the 103 patients developed desaturation. On the other hand, 20 of the 107 patients in the paracetamol arm developed desaturation. Patients who received indomethacin also experienced more rapid symptomatic relief than those in the paracetamol arm, with most symptoms disappearing in half the time. 56 patients out of 107 in the paracetamol arm had fever on the seventh day, while no patient in the indomethacin group had fever. Neither arm reported any adverse event. The fourteenth-day follow-up revealed that the paracetamol arm patients had faced several discomforts, including myalgia, joint pain, and tiredness; indomethacin arm patients mostly complained only of tiredness.ConclusionIndomethacin is a safe and effective drug for treating patients with mild and moderate covid-19.

RR:C19 Evidence Scale rating by reviewer:

  • Reliable. The main study claims are generally justified by its methods and data. The results and conclusions are likely to be similar to the hypothetical ideal study. There are some minor caveats or limitations, but they would/do not change the major claims of the study. The study provides sufficient strength of evidence on its own that its main claims should be considered actionable, with some room for future revision.

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Review:

This opinion is based on:

Does the manuscript confirm previous work or refute the current understanding?

This manuscript challenges current clinical practice using paracetamol based on confirmation of previous theoretical work applied to clinical practice.

How well does the manuscript position the work within the current literature/understanding?

The literature review is selective for relevant prior work and gives adequate theoretical support for this change in clinical practice. The literature review may benefit from updates. For example, the review could address the Omicron variant, as suggested in clarifications in the attached.

I recommend this manuscript for full publishing.

Is there clarity regarding the recommended actions that result from the findings?

It is well-structured and well-written for a general clinical audience and clinical trial specialists. The text would benefit from clarifications as suggested in the attached. It would be helpful to address more explicitly how the benefit of indomethacin over paracetamol, shown here in a hospital setting, may also apply in community or outpatient settings. For example, the prophylactic use of PPI also applies and is simple since these are now available direct-to-consumer. However, indomethacin is a prescription-only drug in most countries, though many have direct-to-consumer supply methods via qualified pharmacists which could be used.

Do authors pay attention to ethics, diversity, and inclusion?

No issues.

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