Hyderabad: Phase III trials of Molnupiravir begin at Yashoda Hospitals

Natco Pharma had recently received approval from the Drug Controller General of India (DCGI) to conduct phase III clinical trials of Molnupiravir

Hyderabad: Yashoda Hospitals on Friday announced commencement of phase III clinical trials of Molnupiravir, the antiviral drug being developed by city-based Natco Pharma to treat patients with mild and moderate Covid symptoms.

Natco Pharma had recently received approval from the Drug Controller General of India (DCGI) to conduct phase III clinical trials of Molnupiravir.

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The trials, to be taken up at the Somajiguda branch of Yashoda Hospitals, will have Covid patient volunteers taking 400 mg twice a day without being admitted in the hospital since it is a OPD (out-patient department) based clinical trial, and have interactions with physicians on Day 5, Day 10 and Day 15 for their follow up cycle at the hospital, officials said.

“It is a privilege to be the first hospital in India chosen for Phase III of clinical trials for this drug. We hope the trial is a success and a game-changer. If patients can be treated with Molnupiravir in the mild stage of the disease, the transmission of Covid-19 can be controlled and further worsening of the disease can be prevented,” Dr. Lingaiah Amidalya, Medical Director, Yashoda Hospitals, said.

According to officials, scientists at Georgia University, USA have predicted that the tablet will take effect within 24 hours of the dose and that oral administration of the tablet on severe Covid patients will also help reduce the severity.

Pre-clinical (animal) studies have found that Molnupiravir can remarkably reduce SARS-CoV-2 load and was found to have completely suppressed the spread of disease from animal to animal, and stopped the virus from multiplying. 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 5 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.

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