NEW DELHI: Phase 3 clinical trials in nearly 2400 people in India have begun to test the efficacy of experimental antiviral drug Molnupiravir against Covid-19, following regulatory approvals by the Central Drug Standard Control Organisation.
This drug, developed by Merck originally, is an investigational oral broad-spectrum antiviral agent that has shown promising results in arresting the mild and moderate Covid-19 cases from deteriorating further as per early-stage trials in some other countries and is now being studied in late-stage trials.
In India, five companies have entered into voluntary licensing agreements to produce generic versions of this drug of which MSN laboratories has received permission to conduct the trials.
Suneetha Narreddy, senior consultant, infectious diseases at Apollo hospital in Hyderabad—which is one of the 40 trial sites in India where the phase 3 trials will be conducted, said that the drug is showing promise for Covid-19 treatment and has a good safety profile.
“Data from early-stage trials and preliminary analysis of phase 3 trials from outside India looks very promising but we should wait till the trials are concluded in India to say something definitive,” she said, adding that the drug is being given to non-hospitalised patients with mild and moderate disease as part of the trial.
“Final analysis will depend on how many of the patients with or without this drug in the placebo and treatment arm went on to develop severe disease or needed hospitalisation,” she said.