The FDA “has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” said Michael Felberbaum, an agency spokesman, in an email.

Chinese Trial
The results from the Chinese study in the Lancet have been long-anticipated. The trial was originally meant to enroll 761 patients in Wuhan, the early center of the country’s outbreak, but researchers couldn’t find enough people after its epidemic ebbed in early March.

Still, the results from 237 adults in the randomized trials, in which neither investigators nor patients knew who was taking the real drug and who was taking a placebo, are a setback for the drug.

Last week, the WHO prematurely and accidentally published results of the China trial but retracted it soon after. The WHO post showed that the drug didn’t show benefit for these patients in terms of preventing death and reducing virus load.

About 100 clinics around the world worked together on the NIAID study, with a central goal of seeing whether remdesivir could help more patients recover more quickly after 29 days of followup.

Unlike the Chinese trial, which was running even as strict containment measures were clamping down on the numbers of infected people, NIAID’s study had the benefit of casting a net for patients just as their numbers were exploding. After initially expecting to enroll 572 patients, researchers later said the total sample size could be more than 800 people.


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