Monday, October 25

Covid nasal spray Phase-III trial at Kol hosp may begin in a week

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 After monoclonal antibody cocktail it could be the nitric oxide nasal spray that doctors will be armed with in the fight against Covid. Like the antibody cocktail, this intranasal spray is expected to prevent mild Covid infection from progressing towards moderate/severe disease. Kolkata will be part of the pan-India Phase III clinical trial to test the safety and efficacy of this newest shield against the virus.
The internal ethics committee of Peerless Hospital has approved the trial which is expected to begin in about a week. Administered through the nasal route with a puff, it will be given to mildly infected patients at outpatient departments. The investigation team at Peerless Hospital said the Phase II trial had shown 99% reduction in viral load at the end of three days of treatment, making the patients negative to the virus. About 30 patients are likely to be enrolled.
The antibody cocktail by the Switzerland-based Roche has already been used on patients in a few hospitals in Bengal. And doctors have found promising results in preventing the patient from getting a severe disease and subsequent hospitalization. But this drug is costly, making it out of bounds for most patients. Health experts said the nitric oxide nasal spray by Glenmark Pharmaceuticals, India is going to be cheaper.

“This is the first intranasal drug formulation against Covid being developed in India. It is the third phase of trial which confirms its safety and efficacy. This is not only going to be cost effective but patient friendly in terms of use. The cost is expected to be much lower than the monoclonal antibody cocktail and this spray can be self-administered,” said Peerless Hospital clinical research and academic director Subhrojyoti Bhowmick. He, along with director critical care unit Ajoy Sarkar, will be the lead investigators of the study.

Patients under the trial will be those mildly infected. Their viral load count will be taken down upon testing positive. They will be given two puffs of the spray six times daily for 10 days. While they need to visit the hospital on Day One when they will be taught to take the puff and also informed about other dos and don’ts, the rest of the drug regime can be followed at home with online consultation with the investigation team. They need to visit the hospital after completing the course. Their health parameters and other indicators like viral load will be assessed to find out the effect of this molecule.
“The molecule will be tried on about 306 patients across India in 10 centres. At Peerless we expect to enrol about 30 patients. Since we already have approval from the CDSCO (Central Drugs Standard Control Organisation) and the hospital’s ethics committee the trial should begin by next week,” said Swapan Biswas, head clinical operations and regulatory affairs at Infoclin Consultancy, the organisation facilitating the trial in Bengal.

Source: Times of India

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