The use of Molnupiravir, an experimental oral drug having antiviral properties, resulted in early recovery of COVID-19 patients with mild symptoms when compared to standard treatment during Phase 3 clinical trials, Indian pharmaceutical company Hetero Drugs said on Friday, July 9, citing interim data.
Hetero had commenced a phase-III, comparative, randomised, multicenter clinical trial on mild COVID-19 patients, it said. These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care (test arm) versus standard of care alone (control arm), in mild COVID-19 patients with a positive RT-PCR test for coronavirus and randomised within five days of onset of symptoms.
In April this year, Hetero had entered into a non- exclusive licensing agreement with MSD, to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs).
There were fewer hospital admissions in Molnupiravir group compared to standard of care alone over 14 days of observation, the interim results said. "Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with Molnupiravir Treatment in mild COVID-19 patients compared to standard of care alone," Hetero said.
There was no mortality in either group and all adverse events were non-serious, mild in severity, and none led to drug discontinuation, the drug maker said.
Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely, according to Hetero, which is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by Central Drugs Standard Control Organisation, the company added.