Ten government and private hospitals across India have been shortlisted to undergo a phase III clinical trial of Favipiravir drug for mild and moderately ill Covid-19 patients.
Favipiravir is an anti-viral that prevents viral duplication in body by inhibiting the enzyme that drives the viral replication. It is commonly used as an anti-influenza drug in Japan and China. In India 150 patients will be undergoing the trial, a 14 day dosage will be administered on patients. The phase III trial results are expected by July-August period this year.
The drug was first manufactured by Japanese Fujifilm Toyama Chemical Ltd. In India Glenmark Pharmaceutical is manufacturing the generic version apart from Strides Pharma that started manufacturing and exporting it to other countries. Glenmark got approval for the clinical trial by Drug Controller General of India (DGCI) in April end.
A clinical trial involving 340 patients in China found the Favipiravir “effective”, the viral load was reduced in four days as compared to the other arm that was not administered the drug. The other arm took 11 days to test negative for coronavirus.
In a statement, Glenmark said, “Glenmark has successfully developed the API and the formulations for the product through its in-house Research and Development team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.” Sujesh Vasudevan, President, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals, said, “We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful.”
In Mumbai, Dr RN Bharmal, director of medical education in BMC, said the trial and its protocol has been put up in front of ethics committee for approval, and patients for Favipiravir are yet to be shortlisted. “It is yet to be decided how many participants will be enrolled here,” Bharmal said.
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Meanwhile in Mumbai, 40 severely ill patients have been treated with Tocilizumab drug, an immunosuppressant, to treat severe lung infection. Of them 14 have recovered fully and got discharged from hospitals. Of 40, in total 30 patients have shown an improvement. On Tuesday a 38-year-old Dharavi resident, who was treated with this drug in Nair hospital, was discharged.
The drug was first tried in Mumbai in Lilavati hospital for a 52 year old man. He was given a three day dose of the drug, but his health did not improve. Tocilizumab is commonly used for arthritis and is now one of the newer drugs being tried to treat critical Covid-19 patients. BMc is using this drug in Nair, KEM, Seven Hills and Sion hospital. BMC officials said they have seen faster recovery with this drug and in several cases patient did not need ventilator support after the medication was given.