Published: Sun, October 18, 2020
Economy | By

World Health Organization defends conclusion that remdesivir is ineffective against COVID-19

World Health Organization defends conclusion that remdesivir is ineffective against COVID-19

US President Donald Trump has also received remdesivir as well as dexamethasone and a cocktail of other drugs for his coronavirus infection, according to White House doctors.

The largest randomised control trial coordinated by World Health Organization for 28 days found the drugs did not have an effect on mortality or the in-hospital course among hospitalised patients with Covid-19.

Remdesivir is now recommended as first-line treatment in NIH clinical guidelines for hospitalized COVID-19 patients who require supplemental oxygen.

The commission "needs to present the reasons behind the rush to conclude the latest contract with Gilead and move to review it in light of the Solidarity Trial findings", said Yannis Natsis, who represents patients' organisations on the board of the European Medicines Agency (EMA), the EU drug regulator. Some studies have shown remdesivir helps hospitalized COVID-19 patients recover faster and slow down the progression of the disease.

There was also no significant difference in mortality for interferon-β1 (RR 1.16, 95% CI 0.96-1.39, P=0.11), nor HCQ (RR 1.19, 95% CI 0.89-1.59, P=0.23) and lopinavir (RR 1.00, 95% CI 0.79-1.25, P=0.97), both of which had previously shown no benefit in other randomized trials.

Then, the authors looked at data on almost 740,000 COVID-19 patients and examined the use of drugs that work to protect these processes, asking whether patients who received them fared better - and they did, in some cases. Chief Scientist of WHO Soumya Swaminathan said she thinks regulatory agencies of countries will reanalyze the trial data and decide whether emergency use should be continued. These drugs were remdesivir; hydroxychloroquine; a combination antiviral treatment already used for HIV called lopinavir-ritonavir; and interferon β1a, a drug derived from our immune cells used to treat multiple sclerosis (initially, the interferon was given in combination with lopinavir, but that stopped after early July).

In the end, no drug or combination reduced mortality, the chances that mechanical ventilation would be needed or time spent in the hospital, compared with the patients without drug treatment.

"It is unclear if any conclusive findings can be drawn from the study results", the company added in a statement.

The trial recorded 301 deaths among 2,743 patients who received remdesivir and 303 deaths among 2,708 control patients who had received best standard care.

"We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design".

The SOLIDARITY trial is the largest randomised, controlled study of its kind.

He added that he hoped some questions about the trial would be resolved either in a revision to the preprint or when the results appear in a peer-reviewed journal. "Covid affects millions of people and their families around the world".

Solidarity continues to recruit about 2,000 patients a month in its search for more effective treatments for COVID-19 with many countries, especially in Europe, now experiencing a surge in new cases of coronavirus. We need scalable, affordable and equitable treatments.

The attention is now turning to new experimental therapies such as antibodies designed in the lab to fight the virus and new, untested, anti-viral drugs.

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