After seeing encouraging results in a pilot study done last year, Indian researchers are now planning to conduct a randomised control trial (RCT) to understand the efficacy and safety of indomethacin in providing faster symptomatic relief and reduction in oxygen requirement in Covid-19 patients.

Indomethacin is a nonsteroidal, anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, stiffness, and swelling caused by rheumatoid arthritis.

In December 2020, Medrxiv published a preprint of a study conducted by a group of doctors, who advanced the case use of Indomethacin for faster symptomatic relief and preventing progression of pneumonia in Covid-19 patients.

“The previous study was more of an experience but this time we are planning to do a RCT, which is more accepted scientifically,” Dr Rajan Ravichandran, senior nephrologist at Chennai’s MIOT Hospital, who conceived the study, told BusinessLine .

“We are planning to start this in a week or so where we will do a controlled study. We will compare people receiving Indomethacin and those without Indomethacin to see what the outcome is and whether it prevents oxygen requirement,” he added.

Drug companies across the world have been repurposing existing medicines to tackle Covid-19. And this study, too, could offer an inexpensive addition to the basket of products available to treat patients, if found to be effective.

“Indomethacin reduces the requirement for oxygen and symptom relief is very fast so that the patient will spread the infection less because they don’t cough much and if the cough subsides, the spread of disease will also come down,” Ravichandran explained.

Pilot study

The earlier study covered 104 Covid-19 positive patients from two different hospitals, and concluded on the promising outcome, after indomethacin was given along with standard care. “It should be considered to replace paracetamol when there is no contraindication for its use,” they said.

The study was supported by Prof R Krishna Kumar, Department of Engineering Design, IIT-Madras, and researchers from Narayana Medical College, Nellore, Andhra Pradesh; and Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra – the two centres where the study was conducted.

Dr Ravichandran said they are planning to cover around 500 patients in the RCT. “We are starting with 100, and we are going to expand as many patients as possible. We are seeing whether ICMR (Indian Council for Medical Research) can be roped in so that more centres can be taken, and we can try it out in a larger way,” said Ravichandran.

On the time required for results, he said while the preliminary results of how it is working on the second wave can be expected in a month, the final results can take up to three months.

“It all depends on the patient’s availability. Right now, patient recruitment can be good because the number of patients is high. So, I would expect results in about 3 months,” said Ravichandran.