Phase III Clinical Trials Of Molnupiravir Drug For COVID-19 Patients Begins At Yashoda Hospital

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The clinical trials for Molnupiravir capsules, a drug for mild COVID-19 symptoms patients, has been launched in a Hyderabad hospital.

On the 21st of May, the Yashoda Hospital in Somajiguda launched the phase III clinical trials for the drug, manufactured by Natco Pharma. The trials began after the Drug Controller General of India (DCGI) gave approval for conducting the phase III clinical trials for the oral administration of Molnupiravir capsules to patients with mild and moderate symptoms of the Wuhan virus.

Dr. Lingaiah Amidalya, the Medical Director of the Yashoda Hospital, said, “It is a privilege to be the first hospital in India chosen for the Phase III of the clinical trials, we hope that the trial is a success proving itself to be 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 at large scale, thus the disease burden on the healthcare system as well as the society could be reduced, with significant implications on the financial burden of the common man and their out-of-pocket expense (sic.)”

Under the third phase trials, the hospital administration would give 400 mg Molnupiravir to patients with mild symptoms twice a day. The physicians of the hospital would monitor the patient’s health on day 5, day 10 and day 15 at the hospital.

Scientifically explained, Molnupiravir is a prodrug of the active antiviral ribonucleoside analog of β-d-N4-hydroxycytidine. Its activity against SARS-CoV-2 commonly known as the Wuhan virus or the Novel Coronavirus (COVID-19) is by inhibition of RNA-dependent-RNA polymerase, which would stop viral replication, shortening the infection and limiting disease transmission.

Scientists at University of Georgiain the United States of America (U.S.A.,) also anticipated the tablet to take effect within 24 hours of the dose. In addition, the scientists said, the oral administration of the tablet on COVID-19 severe patients would also help in reducing the severity of the symptoms.

In the Phase I clinical trial of the drug 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 U.S.A., all patients who received Molnupiravir for 5 days were found to have a negative SARS-CoV-2 culture after the 5 day treatment duration.

Moving ahead with the trials, the third phase clinical trials began on the 21st of May in Hyderabad, Telangana. Later, the clinical trials would be expanded to 32 hospitals in the State.

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