Lucknow: The Central Drug Research Institute (CDRI) has claimed that the clinical trials of antiviral drug, Umifenovir, in treatment of Covid-19, have been a successful exercise.
The trial of Umifenovir on 132 Covid patients showed that, if proper dose is given twice daily for five days, the drug can effectively reduce viral load to zero in mild or moderate symptomatic and asymptomatic patients by checking multiplication of the virus.
Titled ‘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’, the clinical trial was conducted at three institutions – KGMU, Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and Era’s Lucknow Medical College and Hospital (ELMCH).
CDRI director Prof Tapas Kundu said, “Since Umifenovir is a broad-spectrum antiviral and is being used as a safe over-the-counter drug for influenza and pneumonia for over 20 years in Russia, China and other countries. The first two trials were not mandatory.”
The CDRI, therefore, directly went for phase-III trial, conducted on 132 patients either admitted in hospital or in home quarantine under the supervision of these hospitals,” the CDRI director said.
“In a study, double-blind mode improves reliability of results by preventing bias when doctors evaluate patient outcomes. 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,” he said.
Studies by CDRI in collaboration with CSIR-IMT, Chandigarh, also showed that Umifenovir exhibits good cell culture inhibition of SARSCov2, which suggests that the drug inhibits the entry of SARS-Cov2 virus into human cells.
Kundu said the institute was getting the dosage plan patented as it had not been used earlier for Covid-19.
“The Drug Controller General of India (DCGI) has evaluated the clinical trials report and in view of the highly encouraging results and he has asked the team to continue the studies on more mild, asymptomatic patients for grant of emergency approval of the drug,” he added.
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 per cent 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.”
CDRI spokesperson Sanjeev Yadav said, “Umifenovir was selected from 16 drugs suggested by CSIR after looking into the feasibility of synthesis using locally available chemicals at the peak of the pandemic. DCGI then gave permission for trials in June last year.”
After securing ethical approvals and completing stability studies, the team took consent of patients and roped them in for the study.