Lucknow: The Central Drug Research Institute (CDRI) has claimed that the clinical trials of the antiviral drug, Umifenovir, in the treatment of Covid-19, have been a successful exercise. The trial of umifenovir on 132 Covid patients has shown that, if an appropriate dose is given twice a day for five days, the drug can effectively reduce the viral load to zero in mild to moderate symptomatic and asymptomatic patients by checking the multiplication of the virus. Entitled “Phase III, randomized, double-blind, placebo-controlled trial on the efficacy, safety and tolerability of the antiviral drug Umifenovir compared to standard care treatment 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 has been used as a safe over-the-counter medicine for influenza and pneumonia for over 20 years in Russia, China and other countries. The first two tests were not mandatory. “

The CDRI therefore turned directly to the phase III trial, carried out on 132 patients either hospitalized or in home quarantine under the supervision of these hospitals “, declared the director of the CDRI.

“In one study, double-blind mode improves the reliability of results by avoiding bias when physicians assess patient outcomes. The results showed that the viral load in mild, moderate, or asymptomatic patients after receiving two doses of umifenovir (800 mg), twice a day, fell to zero in an average of five days. The patients did not experience any side effects and their symptoms did not become severe either, ”he said.

Studies conducted by CDRI in collaboration with CSIR-IMT, Chandigarh, also showed that umifenovir exhibits good inhibition of SARSCov2 cell culture, suggesting that the drug inhibits entry of SARS-Cov2 virus into human cells.

Kundu said the institute was patenting the dosage plan because it had not previously been used for Covid-19.

“The Drug Controller General of India (DCGI) has evaluated the clinical trial report and, in view of the very encouraging results, has asked the team to continue studies in milder and asymptomatic patients to obtain approval of emergency of the drug. ” he added.

CDRI chief scientist Professor R Ravishankar, who led the team, said: “Umifenovir will be economical to treat Covid-19 patients because it is around 54% cheaper than current drugs. drug is safe for pregnant women and children. We are also examining the possibility of using umifenovir syrup for children and also in powder form for puffy inhalers. “

CDRI spokesperson Sanjeev Yadav said: “Umifenovir was selected from 16 drugs suggested by CSIR after studying the feasibility of synthesis using locally available chemicals at the height of the pandemic. . DCGI then authorized testing in June of last year.

After obtaining the ethical approvals and completing the stability studies, the team obtained patient consent and included them in the study.