Leading experts consulted by the US network NBC News ask for caution when interpreting data from the WHO’s ‘Solidarity’ study, released this Friday and which has not been peer reviewed, in which the efficacy of some potential treatments against the Covid-19, like remdesivir, hydroxychloroquine, the combination of the antiretrovirals lopinavir and ritonavir, and interferon.
Researchers Ken Lyn-Kew, from the National Jewish Health in Denver; Andre Kalil of the University of Nebraska Medical Center in Omaha; and Cameron Wolfe of Duke University School of Medicine.
Dr Andre Kalil, principal investigator of the NIH trial conducted at the University of Nebraska Medical Center in Omaha, has stated that the ‘Solidarity’ trial, which has included data from more than 11,200 people in 30 countries, lacks of some of the critical foundations for scientific research: “There is no data monitoring, there is no placebo, there is no double blind, there is no diagnostic confirmation of infection.” He added that “a poor quality study design cannot be fixed by a large sample size, no matter how large it is.”
For his part, Cameron Wolfe, an infectious disease expert and associate professor of medicine at Duke University School of Medicine, questioned whether the ‘Solidarity’ study was disseminated through the “prepublication” procedure. In his view, this is something that “probably went well in January or February, when we really had a public health emergency and we wanted to get critical information out quickly.”
However, he argues that “we are in a new context in which changing the standard of care through a press release is a really dangerous precedent.”
“It is effective”
In this sense, Wolfe has revealed that “there are higher quality data published on remdesivir that show that” it is effective. He thus alluded to one of the drugs included in the ‘Solidarity’ study and from which new data from the ACTT-1 trial promoted by Niaid were published last week in the ‘New England Journal of Medicine’, which was a double study blind with placebo.
The experts consulted have also indicated that it is not surprising that remdesivir, which received an emergency use authorization from the US Administration in May, does not seem to benefit the sickest patients, since it is an antiviral drug and antivirals they are generally most effective when given early in the disease. Once inflammation has spread through the body, an antiviral drug to reduce the amount of virus in the body would be minimally effective at best.
Along these lines, Lyn-Kew added that “we knew that in the sickest populations, it didn’t really change the results.” “This study just reinforces that it is not a miracle drug,” said this expert from the National Jewish Health of Denver.
For his part, Wolfe highlights that people infected with Covid-19 generally go through an initial phase of infectivity that could benefit from antiviral treatment. “The second phase is much more hyperinflammatory,” Wolfe explained. “It’s probably not surprising that if you’re in the middle of that newly inflamed secondary phase, an antiviral drug has less impact.” This expert has also expressed his frustration that the WHO disseminated the report through a “pre-publication” and without having submitted the study to a review.