The World’s Health Organization (WHO) shared interim results that the Solidarity Therapeutics Trial, the world’s largest randomized controlled trial on COVID-19 therapeutics, generates conclusive evidence that Remdesivir, along with hydroxychloroquine and lopinavir/ritonavir as well as interferon regimens, appears to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
Involving over 30 nations, the study team investigated the effects of these treatments on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients. The Solidarity trial is an accomplishment as it shows that large international trials are feasible despite a major pandemic, offering the possibility of quickly and reliably answering critical public health questions involving novel or repurposed therapeutics. The study results were recently shared in the preprint medRxiv, while the results are under review for publication in a peer-reviewed medical journal.
The Solidarity Trial involved the rapid evaluation of promising new treatment options, with nearly 500 hospitals open as trial sites. The study is now considering new antiviral drugs, immunomodulators, and anti-SARS COV-2 monoclonal antibodies.
Noticeably absent is the antiviral drug Favipiravir, which has been approved in Russia, China, Bangladesh, India, and other nations—at least on an emergency use basis during the COVID-19 pandemic. TrialSite has written extensively on the use of this therapy targeting COVID-19. Moreover, as many know, TrialSite has chronicled the growing real-world data (RWD) associated with ivermectin, not to mention a couple of randomized controlled trials and even now peer review-published observational results (ICON) in the United States. Why can’t a low-cost, economical, and widely available repurposed therapy be included in Solidarity? There are others identified as well.
Implications for Remdesivir?
What are the implications of this trial for the Emergency Use Authorization (EUA) in the United States? As TrialSite documented, the tactics involved in ensuring that this drug was approved for EUA are questionable. See the article published July 31, “Not a Knockout Drug but Knocking it out of the Ballpark: Gilead Windfall as Remdesivir COVID-19 Sales to Hit $1-$3 Billion in 2020”.