Pharmaceutical company Glenmark is set to commence a phase-3 clinical trial to study the efficacy of a combination of Favipiravir and Umifenovir drugs to treat Covid-19. The trial, which will involve 158 Indian patients, is the second trial to start in the country using Favipiravir.
The combination of the drugs will be used to check whether duration of viral shedding can be shortened. Viral shedding, which usually occurs before or at the onset of symptoms, means the virus is expelled from the body and can potentially infect others.
The trial, called Faith, has received approval from regulators. Favipiravir and Umifenovir are both anti-virals. Favipiravir is given orally and expected to prevent viral duplication in the body by inhibiting the enzyme that drives the replication. It is commonly used as an anti-influenza drug in Japan and China. Umifenovir is also used to treat influenza A and B. However, a study published in Clinical Microbiology and Infection on April 25 found Umifenovir did not help in faster recovery of Covid-19 patients. Those administered the drug took 18 days to test negative for coronavirus as opposed to 16 days that patients who were not given the drug took to test negative.
The study observed, “Umifenovir might not improve the prognosis or accelerate SARS-CoV-2 clearance in non-ICU patients. A randomized control clinical trial is needed to assess the efficacy of umifenovir.”
The latest study will assess whether a combination of both drugs works better on moderately-ill patients when they have high viral load and early onset of symptoms. “Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to overall improvement in clinical parameters,” Glenmark vice-president Monika Tandon said in a press statement.
The company is involved in another trial using Favipiravir and involving 150 patients — 30 patients have been enrolled till now.
In Mumbai, BMC officials said hospitals have been shortlisted for the Favipiravir trial but hospitals are yet to get shortlisted for the combination drugs. Dr Om Sriva-stava, an expert on infectious diseases, said Remdesivir and Favip-iravir have shown encouraging results so far, but it has been administered to very few patients in Mumbai. In Mumbai, Umifenovir is yet to be used on patients. “We have not used this combination yet, we have only used Favipir-avir,” said a Lilavati hospital official.
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