In a remarkable breakthrough, Lucknow’s Central Drug Research Institute (CDRI) announced the success of clinical trials for Umifenovir, an antiviral drug to be used in the treatment of COVID-19. As per the study conducted on 132 COVID patients, proper doses of the drug, administered twice daily for a period of five days, can ensure significant results. It has been claimed that the drug can lower viral load to zero in mild or moderate symptomatic and asymptomatic patients.
Trials conducted across 3 centres in the city
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As per a statement released by the organisation, the process was labelled ‘Phase III, randomized, double-blind, placebo-controlled trial of efficacy, safety and tolerability of antiviral drug Umifenovir vs standard care of therapy in non-severe Covid-19 patients.” Under this program, the clinical trails were performed at King George’s Medical University (KGMU), Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and Era’s Lucknow Medical College and Hospital (ELMCH).
Drug directly tested for the phase-3 trials
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CDRI director Prof Tapas Kundu informed that the drug did not undergo the first two trials. It was not required because Umifenovir is a broad-spectrum antiviral, which had been used as a safe over-the-counter drug for influenza and pneumonia for over 20 years in Russia, China and other countries. Thereby, the research body went straight for the phase-3 trials on 132 patients. This group included admitted patients and home-quarantined infected individuals.
Speaking about the findings, the director said, “The results showed that viral load in mild, moderate or asymptomatic patients after being given two doses of Umifenovir (800mg), twice a day, became zero in an average of five days. Patients did not experience any side-effects and their symptoms also did not turn severe.”
More trials required for getting emergency approval for the drug
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According to the inferences of a collaborative study between CDRI and CSIR-IMT, Chandigarh, Umifenovir exhibits good cell culture inhibition of SARSCov2. This indicates that the drug would prevent the entry of the deadly virus into human cells. Now, the institute will get a patent for the dosage plan, given the fact that Umifenovir has not been used for treating COVID-19 previously.
Notably, the Drug Controller General of India (DCGI) has already assessed the report of the clinical trials. On the basis of the fruitful findings, it has asked the team to conduct more tests on mild and asymptomatic patients. This would fasten the process of getting emergency approval for the drug.
An economical & efficient drug for COVID treatment
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CDRI chief scientist Prof R Ravishankar, who led the team, said, “Umifenovir will be economical for treating Covid-19 patients as it is around 54 percent cheaper compared to current medication. The drug is safe for pregnant women and children. We are also looking into the possibility of Umifenovir syrup for children and also in powder form for puff inhalers.”
Further, the spokesperson of the organisation, Sanjeev Yadav informed that the drug has been picked from a list of 16 options suggesting by CSIR. Amongst an array of parameters, the officials also considered the ease of making this drug with locally available chemicals. Thereafter, the DGCI had approved the drug for clinical trials in June last year. Lately, the trials were conducted with the consent of the patients, after ensuring ethical approvals and finishing stability studies.
– With inputs from IANS
