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Large remdesivir clinical trial in US shows new promise

Preliminary results of the trial suggest a 10-day course of remdesivir was superior to placebo in the treatment of hospitalised Covid-19 patients.

Remdesivir, remdesivir drug, remdesivir medicine, remdesivir coronavirus medicine, World news, Indian Express A vial of remdesivir at a Gilead Sciences manufacturing site in the United States. (Gilead Sciences via AP)

A trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) in the United States has found that the broad-spectrum investigational antiviral drug remdesivir can speed up recovery in Covid-19 patients requiring oxygen therapy.

The results of the trial were considered encouraging enough to warrant publication even as the trial was ongoing.

“Preliminary results of the trial suggest that a 10-day course of remdesivir was superior to placebo in the treatment of hospitalised patients with Covid-19. This benefit was seen in the number of days to recovery… Even though the trial was ongoing, the data and safety monitoring board made the recommendation to unblind the results to the trial team members from the NIAID, who subsequently decided to make the results public.

“Given the strength of the results about remdesivir, these findings were deemed to be of immediate importance for the care of patients still participating in the trial as well as for those outside the trial who might benefit from treatment with remdesivir,” the researchers reported in The New England Journal of Medicine on Friday.

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The estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo.

The National Institute of Allergy and Infectious Diseases is part of the National Institutes of Health (NIH), an agency of the US Department of Health and Human Services.

Remdesivir, manufactured by the biopharma company Gilead Sciences Inc., has been previously tested in humans with Ebola virus disease, and has shown promise as a drug against Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), both of which, like Covid-19, are caused by coronaviruses.

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The drug is under testing for specific treatment of Covid-19, and is seen as one of the most promising therapies against the disease. Six major trials or studies involving remdesivir are currently under way, including the World Health Organisation’s (WHO’s) Solidarity Trial, under which it is likely to be used in Indian patients as well.

Earlier this month, the US Food and Drug Administration (FDA) authorised emergency use of remdesivir for treatment of adults and children with severe Covid-19 disease.

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In an earlier, truncated study published in The Lancet medical journal, Chinese researchers had reported they could not find any “statistically significant clinical benefits” of the drug.

The NEJM study flagged the high mortality despite use of remdesivir.

“These preliminary findings support the use of remdesivir for patients who are hospitalised with Covid-19 and require supplemental oxygen therapy. However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” the researchers said.

“Future strategies”, they said, “should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue to improve patient outcomes in Covid-19.”

Meanwhile, India reported a new high of 6,654 fresh cases on Saturday morning, taking the total number of cases to 1,25,101. There were 137 deaths, taking the toll to 3,720.

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Health Secretary Preeti Sudan had a review meeting with senior state and municipal officials from the 11 municipal areas which have high case load of Covid-19. These municipal areas are in Maharashtra, Tamil Nadu, Gujarat, Delhi, Madhya Pradesh, West Bengal, and Rajasthan, and account for 70 per cent of India’s active case load.

It was pointed out that testing needs to stepped up in some municipal areas to ensure early detection of cases, timely clinical management, and a reduction in fatality rate.

First published on: 24-05-2020 at 01:19:57 am
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