ICMR EYES TRIAL TO STUDY EFFICACY OF THERAPIES USED IN COVID TREATMENT

NEW DELHI: The Indian Council of Medical Research (ICMR) is planning an adaptive clinical trial of mild Covid-19 patients to test the safety and efficacy of several therapies used in treatment, including antiviral drugs that have been allowed under restricted use.

For the process, ICMR has floated an expression of intent for hospitals and institutions to participate in the initiative, on which it will be collaborating with the Drugs for Neglected Diseases Initiative (DNDI) to execute the project. “ICMR along with Drugs for Neglected Diseases Initiative (DNDI) is proposing to conduct a multi-centre, adaptive platform trial in mild Covid-19 patients, titled ‘An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild cases of Covid-19’,” says the document uploaded on ICMR’S website.

In an adaptive clinical trial there is flexibility of making modifications in either dose, or regimen, etc prospectively based on the response as the process goes forward. It will be a phase 3 trial as therapies are already used to treat some other health conditions, and have been repurposed to treat Covid-19.

The primary objective of the trial is to compare the efficacy of alternative treatment strategies versus control on the risk of progression to moderate or severe respiratory disease.

The study duration will be 22 days, and according to the proposal document, between 2,000 and 3,000 patients will be included.

The deadline for receiving responses from those eager to participate is June 15.