An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
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- Evaluated articles (Rapid Reviews Infectious Diseases)
Abstract
Indomethacin, 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. A total of 210 RT-PCR-positive COVID-19 patients who provided consent were allotted to the 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 SpO 2 ≤ 93, while time to become afebrile and time for cough and myalgia resolution were the secondary endpoints. The 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. In addition, 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 a SpO 2 level of 93 and below was the vital 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. In addition, 56 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; indomethacin arm patients mostly complained only of tiredness. Indomethacin is a safe and effective drug for treating patients with mild and moderate covid-19.
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Colin Brown
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.
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Vikas Sukhatme
Review 1 : "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.
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Strength of evidence
Vikas Sukhatme (Emory University) | 📗📗📗📗◻️
Colin Brown (Edinburgh Napier University) | 📗📗📗📗◻️ -
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SciScore for 10.1101/2021.07.24.21261007: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Patients who were RT-PCR positive for Covid-19 were recruited using a block randomization parallel group protocol [22] for the efficacy and safety of indomethacin after obtaining the Ethics Committee clearance and consent from the patients.
Consent: Patients who were RT-PCR positive for Covid-19 were recruited using a block randomization parallel group protocol [22] for the efficacy and safety of indomethacin after obtaining the Ethics Committee clearance and consent from the patients.Sex as a biological variable not detected. Randomization Patients who were RT-PCR positive for Covid-19 were recruited using a block randomization parallel group protocol [22] for the efficacy and safety of … SciScore for 10.1101/2021.07.24.21261007: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Patients who were RT-PCR positive for Covid-19 were recruited using a block randomization parallel group protocol [22] for the efficacy and safety of indomethacin after obtaining the Ethics Committee clearance and consent from the patients.
Consent: Patients who were RT-PCR positive for Covid-19 were recruited using a block randomization parallel group protocol [22] for the efficacy and safety of indomethacin after obtaining the Ethics Committee clearance and consent from the patients.Sex as a biological variable not detected. Randomization Patients who were RT-PCR positive for Covid-19 were recruited using a block randomization parallel group protocol [22] for the efficacy and safety of indomethacin after obtaining the Ethics Committee clearance and consent from the patients. Blinding not detected. Power Analysis not 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: 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.
Results from scite Reference Check: We found no unreliable references.
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