Indomethacin Use for Mild & Moderate hospitalised Covid-19 patients: An open label randomized clinical trial

Abstract

Background Indomethacin has shown to be a broad spectrum anti-viral agent apart from it being a non-steroidal anti-inflammatory drug (NSAID). This randomized clinical trial in a hospital setting is to evaluate the efficacy and safety of this drug in RT-PCR positive Covid patients. Materials and Methods RT-PCR positive Covid-19 patients, who gave the consent for the trial, were allotted to a control, or case, arm based on block randomization procedure. The control arm received the standard care consisting of paracetamol, ivermectin and other adjuvant therapy. The case arm had indomethacin instead of paracetamol, retaining the other medications. The endpoint was the development of hypoxia/desaturation. Secondary endpoints were time to become afebrile and time to resolution of cough and myalgia. The results of 210 patients were available at this point, with 102 patients in the indomethacin arm and 108 in the paracetamol arm. The complete patient profile along with everyday clinical parameters were monitored. Blood chemistry at the time of admission and discharge were also carried out. Results As no one required high-flow oxygen, desaturation with an SpO2 level of 93 and below was considered an important goal. In the indomethacin group, no one out of the 102 patients developed desaturation. On the other hand, 20 of the 108 patients in the paracetamol arm developed desaturation. Patients who received indomethacin also experienced more rapid symptomatic relief compared to those in the paracetamol arm, with most symptoms disappearing in half the time. A total of 56 patients out of 108 in the paracetamol arm had fever on the seventh day, while no one recorded fever in the indomethacin arm. No adverse event was reported in either arms. A fourteenth day follow up revealed that the paracetamol arm patients had several discomforts including myalgia, joint pain and tiredness while the indomethacin arm patients complained only of tiredness. Conclusion Indomethacin is a safe and effective drug for the treatment of mild and moderate Covid-19 patients.

A Review of the Potential Roles of Antioxidant and Anti-Inflammatory Pharmacological Approaches for the Management of Mild-to-Moderate Symptomatic COVID-19

“…To do this, it would be useful to carry out studies in which the basic combination therapy could be modified by the addition of a new component or the subtraction of any of the existing ones. A model of this approach was followed by Ravichandran et al [ 164 ], who formed 2 groups given the same multitherapy and differing only in that one was given paracetamol and the other indomethacin. Ideally, this type of comparative, or “non-inferiority”, research between different treatment models could be carried out in randomized trials, although the organizational difficulties would be considerable and double blinding seems objectively difficult to achieve.…”