The Drug Controller General of India (DCGI) has instructed pharma major Biocon to revise its clinical trial protocol for conducting phase-4 studies on Itolizumab used to treat Covid-19 patients.

Itolizumab, a drug used in a skin condition, Psoriasis, is now being re-purposed for treating Covid patients. Re-purposing a drug means prescribing it for newer indications; in this case for Covid, other than what the drug is usually used for.

Biocon presented the protocol for conducting phase-4 clinical trial to evaluate the safety and efficacy of Itolizumab dosage of 25 mg/5 ml solution for intravenous infusion in vials to treat cytokine release syndrome in Covid patients suffering from moderate-to-severe acute respiratory condition. “After detailed deliberation, the committee recommended that the protocol be amended for further review of the committee,” a DCGI official said.

Revise study design

The committee has recommended that the design of the study should be revised with safety as the primary objective. Also, the sample size should be increased based on statistical calculation, the committee has stated, adding that the sites of the study should be geographically distributed across the country.

Phase-4 trials are meant to involve a few thousand participants where investigators get more information on medication’s long-term safety, effectiveness and any other benefits. Currently, a full course of four vials of the drug costs ₹32,000.

The drug has been under controversy since the the DCGI waived phase-3 trials and directly accelerated the drug to phase-4 trials. Phase-3 of a clinical trial involves a few thousand participants in whom the new medication is meant to treat, and these trials can last for several years. They are meant to examine the safety and efficacy of the drug and participants are randomly selected to receive the new medication. They are also double blind, which means neither the investigator nor the participant knows which medication is being given to the participant.

More trials wanting

The Covid-19 National Task Force, headed by NITI Aayog member (health) Vinod Paul, has not recommended the addition of Itolizumab in the Ministry of Health’s clinical management guidelines for Covid. Director General of Indian Council of Medical Research Balram Bhargava has said that more clinical trials are wanting for Itolizumab and Roche drug Tocilizumab.

Last month, Biocon announced results of its phase-2 trials conducted in a sample size of 30 patients, of which 20 were administered the drug. The company said that, simultaneously, up to 150 patients were administered this drug ‘off-label,’ even as the phase-2 trials were ongoing.

‘Off-label,’ use does not require DCGI’s permission and any treating physician can prescribe the use of drug ‘off-label,’ if s/he believes that it can save a patient’s life. Later, DCGI accorded restricted emergency use approval for the drug and granted a waiver for phase-3 trials.

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