Yashoda Hospitals, Somajiguda, in association with Natco Pharma announced the commencement of oral administration of Molnupiravir phase III clinical trials for patients with mild and moderate COVID-19 symptoms, following the nod of the Drugs Controller General of India on Friday.
The clinical trials will entail the COVID patient volunteers to take 400 mg twice a day without being admitted in hospital since it is an out-patient department-based clinical trial, and have regular interactions with their physicians on day 5, day 10 and day 15 for their follow-up cycle at the hospital.
Stops viral replication
Molnupiravir leads to errors in the viral RNA sequence, stopping viral replication, shortening infection, and limiting disease transmission. Scientists at Georgia University, USA, have anticipated that the tablet takes effect within 24 hours of the dose being administered and that oral administration of the tablet on severe patients will help reduce severity of the symptoms, said Yashoda Hospitals medical director Lingaiah Amidalya.
Addressing a press conference, he said pre-clinical (animal) studies have found that Molnupiravir has remarkably reduced SARS-CoV-2 load and was found to have completely suppressed the spread of disease from animal to animal, and the virus multiplication development had stopped.
Deemed safe
In a Phase-I clinical trial conducted in the United Kingdom, Molnupiravir was deemed to be safe and well tolerated up to 800 mg twice a day for five days in healthy trial subjects.
In the Phase-II clinical trials conducted in the USA, all patients who received Molnupiravir for five days were found to have a negative SARS-CoV-2 culture after the five-day treatment duration.
‘Hope it’s game changer’
“We are privileged to be the first hospital in the country to be chosen for these clinical trials. We hope it will be a success proving itself to be a game changer. If patients can be treated with Molnupiravir in the mild stage of the disease, COVID transmission can be controlled and further worsening of the disease can be prevented on a large scale. It would reduce the disease burden on the healthcare system as well as the society, with significant implications on the financial burden of the common man,” explained the doctor.
