Four coronavirus drugs have been shown to have “little or no effect” on hospital patients, according to preliminary results from a World Health Organization study.
The expected results of the WHO multi-country solidarity trial were published Thursday ahead of peer review in medRxiv, which evaluated remdesivir, hydroxychloroquine, interferon and a combination of anti-HIV drugs lopinavir-ritonavir.
“The main results of mortality, initiation of ventilation and length of hospital stay were clearly not reduced by any drug in the study,” according to the study.
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While hydroxychloroquine and lopinavir were withdrawn from the WHO trial over the summer due to futility, the results for remdesivir contrast directly with the results of a study conducted in the United States by NIH, which showed that patients shortened the road to recovery by about four to five days. These findings were recently confirmed by a final report, which John Beigel, associate director of clinical research in the division of microbiology and infectious diseases at NIAID, told TIME that “these data reinforce the value of Remdesivir in hospitalized patients.
The drugmaker of remdesivir, Gilead Sciences, has released a statement expressing concerns about the WHO trial.
“The emerging data appear inconsistent with the stronger evidence from several randomized controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury® (remdesivir),” company officials wrote. “We are concerned that the data from this open, global trial has not undergone the rigorous review required to allow for constructive scientific discussion, especially given the limitations of the trial design. ”
Gilead previously conducted its own clinical trials on the drug and found that 65% of moderately ill patients had improvement after 11 days.
The WHO study involved more than 11,000 adults in 405 hospitals in 30 countries across multiple treatments tested against a control arm; 2,750 patients received remdesivir. (The NIH study involved 1,062 patients who were randomly assigned to either remdesivir or a placebo for 10 days.)
In the company statement sent to Fox News, Gilead highlighted “the significant heterogeneity of the WHO trial in adoption, implementation, controls and patient populations” because the design of the trial prioritized wide access.
WHO chief scientist Dr Soumya Swaminathan praised the Solidarity trial on Wednesday, calling it a “wonderful global collaboration” that has benefited from the preparations and investments made in recent years, after learning from Ebola and other outbreaks. She said as the COVID-19 trials approached, investigators knew how to quickly write protocols, ideas were being shared around the clock, and drug makers showed up to donate drugs.
She called it a “good experience” overall, and on Wednesday before the data was released, she said next projects would involve monoclonal antibodies, immunomodulators, and new antiviral drugs developed in recent months.
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