For the remdesivir arm of the WHO's Solidarity trial, 2,743 patients were given the treatment, compared to 2,708 in the control group.Gilead's own study, of 1,062 participants, produced data indicating that the treatment cut COVID-19 recovery time by five days and helped reduce the risk of death in some patients who were getting oxygen.
The company, which has raised the possibility of bias in the"unblinded" WHO study because patients and their doctors were aware of which treatments were being used, got initial data showing that remdesivir failed the Solidarity trial in late September, the WHO has said."We have apprised FDA of the topline WHO Solidarity trial results and the draft manuscript", submitted to a publication, it said.
The WHO also said on Friday that its formal guidelines on use of remdesivir for COVID-19 should be ready for release in three to four weeks, after a separate group within the United Nations health agency reviews data from the study. An independent WHO panel will convene next week to look at all evidence of the effectiveness of Gilead's drug, Janet Diaz, the WHO's top official for clinical care responses, said.
"We would anticipate that the guidelines will be available within three to four weeks," Diaz said."What we're doing now in the pandemic is to try to continue with that approach in a transparent and trustworthy way, but do it faster."
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