Scientists defend trial questioning Remdesivir’s covid benefits

Henrietta Brewer
October 17, 2020

The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

India will reassess the protocol for COVID-19 treatment in the wake of interim results published by the World Health Organization of the trial which found that remdesivir, the antiviral drug widely prescribed against coronavirus, has no substantial effect on mortality, initiation of ventilation or duration of hospital stay.

Gilead Sciences' antiviral remdesivir got an emergency authorization from the FDA to treat COVID-19 in May on the basis of a study showing the drug cut the recovery time for hospitalized patients by 31%. But WHO posted them to a pre-print server.

"There wasn't any evidence it had any material effect on the time to discharge", he said in a briefing Friday.

"I do think the guidelines will need to be revised to take Solidarity into account given its size and primary finding, particularly when additional detail is available on the analysis", he told MedPage Today.

In a statement, Gilead said it was "concerned" that the data from the trial had not undergone vigorous review, and that it was unclear whether any "conclusive findings" could be drawn from the results.

WHO said in a statement: "The progress achieved by the Solidarity Therapeutics Trial shows that large global trials are possible, even during a pandemic, and offer the promise of quickly and reliably answering critical public health questions concerning therapeutics".

The Indian Council of Medical Research (ICMR) was also an active partner in the Solidarity Therapeutics Trial conducted under the aegis of the WHO. The unreviewed manuscript has been published online.

Nel said even though the result was negative, it was still important to have this data available. The company on October 8 announced a procurement agreement with the European Union to supply as many as 500,000 doses.

An open label trial means that both the researchers and participants know which drug is being given to participants.

The findings, one senior critical care medicine specialist said, imply that low-priced steroids such as dexamethasone and methylprednisolone, also approved for Covid-19 are the "only things proven to reduce mortality". The EU's authorization of the drug was based on data from the US study conducted by the NIAID, according to the statement.

Some scientists said Gilead's complaints merit scrutiny. The company's joint procurement deal enables - but doesn't obligate - European countries to purchase remdesivir, according to the email.

Prior to the World Health Organization study, a large controlled study of remdesivir in the USA found that it shortens recovery time by about a third in severely ill, hospitalized adults with Covid-19, but does little to help those with milder cases.

The trial wasn't created to answer whether there may be a benefit for patients treated early after symptoms begin, as opposed to early after hospitalization.

Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes.

"It's always better to stop a fire happening than put one out", Russell said.

Other reports by iNewsToday