The Solidarity Trial is the world's largest randomized controlled trial of Covid-19 therapeutics, involving nearly 13,000 patients in 500 hospitals in 30 countries.
Gilead in a statement to the Financial Times said "the emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of remdesivir".
A new study out Thursday shows remdesivir, the only antiviral therapeutic approved for treatment of the novel Wuhan coronavirus, does not prevent deaths in COVID-19-infected patients.
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".
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.
In comparison, the experts said, a key United States study that had influenced the regulatory decision to approve emergency authorisation use had involved 1,062 patients.
The adaptive study initially had four arms - HIV drug Lopinavir/Ritonavir, anti-viral drug Remdesivir, anti-malarial drug Hydroxychloroquin and immunomodulator Interferon Beta-1a.
The Solidarity trial, which has not yet been peer-reviewed, found Remdesivir did not "substantially affect mortality", reduce the need to ventilate patients, or shorten hospital stays.
The European Union should renegotiate a 1 billion euro ($1.2 billion) contract it sealed last week with Gilead for a six-month supply of the COVID-19 drug remdesivir after it showed poor results in a large trial, experts said on Friday. "We are concerned that the data from this open- label global trial have not undergone the rigorous review required to allow for constructive scientific discussion", Gilead said in a statement.
Gilead questioned the findings, saying that Solidarity "prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results". "This is real world evidence". In other words, though it's possible that future trials could still find some benefit here, possibly for select groups of covid-19 patients, the big picture for any of these drugs isn't looking great.
The UN health agency said remdesivir appeared to have little or no effect on keeping people alive or on the length of hospital stays among patients with the respiratory disease.
World Health Organization chief scientist Soumya Swaminathan said on Wednesday that their trials on hydroxychloroquine and lopinavir/ritonavir were stopped in June because they had already proven ineffective.
"A major clinical breakthrough looks different and warns us that the battle against Covid-19 is far from won".
The results have not been published in a journal or reviewed by independent scientists, but were posted on a site researchers use to share results quickly. We need scalable, affordable and equitable treatments.