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A study published in Lancet today showed no clinical benefit from remdesivir for hospitalized COVID-19 patients while Anthony Fauci, M.D., said positive - but unpublished - results from a different placebo-controlled trial sponsored by his institute marked a major turning point in COVID-19 treatment.
Fauci, who is director of the National Institute of Allergy and Infectious Diseases (NIAID), compared the positive results for remdesiver to the early positive results for AZT as a treatment for HIV.
“This is opening the door to the fact that we now have the capability of treating” COVID-19, Fauci told reporters sitting on a couch in the Oval Office with President Trump looking on. “And I can guarantee you as more people, more companies, more investigators get involved, it is going to get better and better.”
AZT turned out to have a modest effect, Fauci noted, but he added that it led to HIV treatment that combined a variety of drugs that attacked the virus in different ways. F
The findings published in Lancet were also from a placebo-controlled, multi-site trial of remdesivir as treatment for hospitalized COVID-19 patients, and the primary endpoint, time to improvement, was similar to the NIAID trial. But the results reported by Yeming Wang and has co-investigators in China showed no statistically significant advantage for treatment with remdesivir compared with the placebo, although they said some data hint that starting the antiviral relatively soon after the onset of COVID-19 symptoms may make a difference.
Fauci said the NIAID trial, called the Adaptive COVID-19 Treatment Trial, showed a statistically significant difference in the primary endpoint, time to recovery, between patients randomized to remdesivir and those in the placebo group. The time for recovery for the remdesivir group was 11 days compared with 15 for the patients in the placebo group, Fauci said in the Oval Office.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Fauci told reporters.
For the purposes of the NIAID study, recovery was defined as being in the hospitalized but not needing supplemental oxygen, being discharged but needing oxygen at home, or being discharged with no limitations on activities.
Fauci said the difference in deaths - 8% in the remdesivir group compared with 11% in the placebo - had not yet reached statistical significance.
Fauci said remdesivir, which was originally developed as drug to treat inhibits Ebola, would become the standard of care in research studies of COVID-19 treatment. The New York Times reported that the FDA is likely to approve remdesiver on an emergency basis.