The United Kingdom is set to launch another trial to generate more data on the benefits and side effects of the anti-Covid pill mollupiravir, said Dr Mahendra G Patel, one of the national heads for the Panoramic Study at the University of Oxford. told News18. com.
The UK was the first country to license the antiviral after it was approved by other top drug regulators, including the United States FDA. On the same lines, the Drug Controller General of India endorsed the pill on 28 December.
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However, on January 5, the head of India’s largest medical research institute, the Indian Council of Medical Research (ICMR), cast doubt on the drug’s safety profile and banned it from being part of the country’s COVID-19 treatment protocol.
In a weekly press briefing, ICMR Director General Dr Balram Bhargava said that “the drug has major safety concerns”.
Commenting on the development, Dr. Patel said, “Preliminary efficacy data in countries outside the UK has shown significant benefit with its use, with up to a 30% reduction in hospitalizations. However, these results are an unequaled were in the population.
He added that “the trial will help bring clarity on the benefits in terms of improvement in symptoms, reduction in hospitalization as well as any side effects or adverse effects.”
The study is significant as the trial of Molnupiravir will be conducted among a clinically vulnerable population who were found positive with early symptoms of Covid-19. In parallel, the trial will generate important data on the drug’s effectiveness on the vaccinated population, in addition to indicating its effectiveness against the latest rapidly spreading version of the virus, Omicron.
Antivirals, which many have called a “game changer”, introduce errors into the genetic code of the coronavirus, which prevents it from repeating further. So far, the drug has been tested only among illiterate populations.
“The trial also allows the evaluation of the drug’s effectiveness against newer forms such as Omicron, which is now most efficacious in the UK,” Dr Patel said. The UK population that is now majorly vaccinated.”
The trial recruits people aged 50 years and above or anyone aged 18 years and above who have an underlying condition such as diabetes, heart disease, etc., which may increase their chances of becoming seriously ill. Is.
Results will be available in the shortest possible time
The trial – which is a UK government national high priority study led by Oxford University’s Primary Care Clinical Trials Unit – has already enrolled more than 2,700 patients since its launch in early December. It aims to enroll 10,600 patients who have tested positive for COVID.
The major objective of the trial is to find out the effectiveness of novel antiviral agents for early treatment of COVID-19 in the community. It will also test Pfizer’s oral antiviral Paxlovid.
According to Dr Patel, who is an academic pharmacist, the test results will be available in the shortest possible time.
“Being a stage trial there is no obligation to wait until the end of recruitment once there is significant evidence in terms of its benefits or otherwise (with results analyzed independently on a regular basis), the effectiveness of the treatment is announced. Necessary and appropriate recommendations can be made,” he explained. “If the drug is effective, the sooner the data is collected, the sooner it can be considered how it can be delivered to those most in need. Is.”
The panoramic trial, he said, “will include other licensed antiviral agents in the coming months, along with Pfizer’s Paxlovid, which is now licensed and will be evaluated next”.
Trial to exclude pregnant women
Dr Bhargava of ICMR had also said that Molnupiravir can cause abnormalities in the development of children if it is consumed during pregnancy or by those planning to conceive.
According to Dr Patel, who is also a visiting professor of pharmacy at the University of Bradford, the planned trial in the UK does not include pregnant women and lactating women, “because very few instances have found some evidence of teratogenic effects”. .
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The test only includes people of reproductive age who are confirmed to have taken the strictest possible contraceptive measure.
However, he added that there is no solid evidence of teratogenic effects yet.
“Furthermore, to highlight that the MOVe-OUT study, a phase III double-blind, randomized placebo-controlled trial, compared mollupirvir in the treatment of COVID-19 without obvious safety concerns, with results published in the New England Journal. Reported to be effective. of Medicines (NEJM), ”said Dr. Patel.
Teratogenicity means the ability of a drug to cause fetal abnormalities or to inhibit the formation of an embryo or fetus, intentionally or unintentionally, by pregnant women.
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