The only drug in the U.S. currently approved to treat COVID-19 patients may not have a significant effect on those with a moderate form of the virus, according to a study published Friday in JAMA.
A previous study of 1,059 patients with severe COVID-19 showed remdesivir shortened recovery time by 31%—11 days for those given the drug intravenously versus 15 days for those given just standard care. This study, authored by scientists from 12 different countries, sought to quantify if remdesivir had the same effect on patients with moderate COVID-19. The study results indicate remdesivir had more of an impact on patients who received a 5-day course than a 10-day course. However, even for those in the 5-day course group, the statistically significant difference in clinical status compared with standard care was deemed to be “of uncertain clinical importance.”
The randomized phase 3 trial included 584 patients with moderate COVID-19 that received either a 10-day course of remdesivir (197 patients), a 5-day course of remdesivir (199 patients), or standard care (200 patients). The endpoint of the study was clinical status on day 11 post-treatment.
According to the results, on day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status than those receiving standard care. But, the clinical status on day 11 between the 10-day remdesivir and standard care groups was not significantly different.
By day 28, nine patients had died: two in the 5-day remdesivir group, three in the 10-day remdesivir group, and four in the standard care group. Additionally, nausea, hypokalemia and headaches more frequent among remdesivir-treated patients compared with those who received standard care.
Even with the 5-day course group showing better odds, the authors concluded the difference was “of uncertain clinical importance” since most patients in the 10-day group were well enough to leave the hospital before finishing the full course of their treatment—the median length of their treatment was just six days. Thus, the study adds more of a “maybe” than a concrete yes or no to the growing body of literature on remdesivir.
In an occupying editorial, Erin McCreary and Derek Angus, two of the study authors from the University of Pittsburgh Medical Center, questioned whether remdesivir is less effective than hoped and—given the surge in demand from patients and physicians—if cheaper, more widely available options are a better fit. The steroid dexamethasone, for example, has shown early promise in clinical trials.
"Whether remdesivir offers incremental benefit over corticosteroids, which are widely available and inexpensive, is unknown," the authors wrote.
Ultimately, McCreary, Angus and the study results all indicate more research on remdesivir is needed to truly understand which patients, if any, benefit from the drug and which do not.
"There's a sweet spot,” Taison Bell, an infectious disease physician at the University of Virginia who was involved in the May NIH study, told Business Insider. "You need to target patients who are sick enough, but not too sick. We need to do further studies to determine what that patient population is."