CSIR-Central Drug Research Institute (CSIR-CDRI), Lucknow, has successfully completed ‘Phase III, a 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’. CSIR had earlier started a drug-repurposing effort on a war-footing under the visionary leadership of the Director-General Prof. Shekhar C. Mande as part of a multi-pronged approach to counter the COVID-19 pandemic.

Director, CSIR-CDRI, Prof. Tapas Kundu mentioned that Umifenovir (Arbidol) was selected from among 16 suggested candidates of CSIR looking into the feasibility of synthesis using locally available chemicals at the peak of the pandemic. Prof. R. Ravishankar who coordinated the team said that Umifenovir is a broad-spectrum antiviral and has been used as a safe over-the-counter drug for Influenza and pneumonia for over 20 years in Russia, China and other countries. 

The CDRI team of chemists including Drs Ajay K. Srivastava, Chandra Bhushan Tripathi, Nayan Ghosh and Nilanjana Majumdar and their students synthesized the drug and transferred the technology to M/s Medizest, Goa, within a month to make the API and tablets for the trials.

Mr Navin Sheldenkar of M/s Medizest said that it was a marvel that it was done in a record time and that too technology transfer by video conferencing due to the pandemic restrictions. DCGI subsequently permitted in June last year to carry out the Phase III trials on Asymptomatic, Mild and Moderate COVID-19 patients in King George’s Medical University (KGMU), Era’s Lucknow Medical College and Hospital, and Ram Manohar Lohia Institute of Medical Sciences (RMLIMS). Between 3 October 2020 and 28 April 2021 after securing ethical approvals and completing the stability studies of the drug at CDRI, patients were recruited. Availing the enhanced expertise at CDRI, the scientists decided on a simple dose regimen of 800 mg BID for a maximum of 14 days based on literature analysis.

They also showed that Umifenovir exhibits good cell culture inhibition of SARS-CoV-2 in collaboration with CSIR-IMT, Chandigarh. Mode of action studies carried out by the CDRI team suggests that it inhibits the entry of the SARS-CoV-2 virus into human cells. The team has completed an independent audit of the clinical trials data and statistical analysis as per the approved DCGI protocol which shows that Umifenovir is very promising in mild-asymptomatic COVID-19 patients. The Drug Controller General of India (DCGI) has evaluated the clinical trials report and in view of the highly encouraging results, has asked the team to continue the studies on more mild-asymptomatic patients for granting emergency approval of the drug.

Prof. Kundu mentioned that the present trial is the first double-blind placebo-controlled clinical trial study involving Umifenovir. The dosage used in the study has not been tested earlier against SARS-CoV-2 and is in the process of being patented by CDRI. Dr Himanshu Reddy and Dr Virendra Atam, PIs at KGMU, mentioned that the faster recovery of corona patients will reduce virus shedding and consequent spread of the infection to others. Dr MMA Faridi of Era University mentioned that Umifenovir can be prescribed for pregnant women and children too when approved. Dr Vikram Singh of RMLIMS suggested that as Umifenovir is safe and has significant efficacy in mild-asymptomatic patients, it may be useful as a prophylactic for high-risk patients.

Prof. Tapas Kundu added that CSIR-CDRI is standing strong with the State of Uttar Pradesh and the Nation in the fight against COVID-19. The diagnostic laboratory at CDRI has screened nearly 3 lakh patient samples. CSIR-CDRI has also developed an indigenous RT-PCR kit where the fluorophores have been developed at CSIR-CDRI – the technology has been transferred to a company. 

CSIR-CDRI is also carrying out a whole genome analysis of virus strains from several hundred patients as requested by the State government of Uttar Pradesh. These studies are helping analyze the spread of various SARS-CoV-2 strains in Uttar Pradesh. Keeping in mind the emerging viral infections, CDRI has established a ‘Unit of Excellence in Virus Research and Therapeutics’ under the guidance of the Hon’ble Chief Minister Yogi Ji who encouraged the Dr A.P.J. Abdul Kalam Technical University (APJAKTU) and KGMU to collaborate with CDRI on this important initiative.