Companies are racing to find an effective drug to use against the coronavirus that causes COVID-19, and a trial study for remdesivir showed early treatment increases the chances a person will leave the hospital.
On Day 14 of the study, 62 percent of patients who received the drug within 10 days of symptoms onset were able to be discharged from the hospital. Only 49 percent of those who received treatment after more than 10 days of symptoms were able to be released, according to Gilead Sciences, which produces remdesivir.
Officials worldwide have reported more than 3 million cases of SARS-CoV-2, the official name for the virus, and as of Wednesday, 218,456 people have died. While there's no known treatment for the virus's disease, COVID-19, companies are searching for a safe and effective treatment, as it could save lives and help speed up the process of easing social restrictions aimed at stopping the virus from spreading.
Remdesivir, an antiviral drug, is being studied in trials in multiple countries, but without significant research, it's unclear if it'll prove itself to be the treatment the world needs.
The Phase III SIMPLE trial evaluated five- and 10-day dosing durations in hospitalized patients with severe cases of COVID-19. All 397 patients from 15 countries in the study had evidence of pneumonia and reduced oxygen levels that didn't require mechanical ventilation. Patients were given a standard of care, as well as remdesivir, for either five or 10 days.
Topline results from the trial showed patients who received the drug for 10 days had improvements similar to those in patients who took the drug for only five days. More than half of patients in both treatment groups were discharged from the hospital by Day 14, and the time to clinical improvement for 50 percent of patients was 10 days in the five-day treatment group and 11 days in the 10-day group.
"The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir," Dr. Merdad Parsey, Gilead's chief medical officer, said in a statement. "This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care."
After news broke of Gilead's trial results, Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration, reposted a Twitter thread from April 5 that described the importance of having a treatment. Without effective drugs, the virus will circulate in the background of society, according to Gottlieb, forcing America to operate with an 80 percent economy. But medicine can't be the sole solution.
"None of these drugs is a complete solution. But they can be a bridge to [a] vaccine and interim step powerful enough to restore confidence; save lives," Gottlieb tweeted. "Coupled [with] tools of public health, with a drug in our bag, we can make #COVID19 a manageable threat. The stakes could not be higher."
The National Institute of Allergy and Infectious Diseases is also conducting a trial with the drug. Gilead claimed that "positive data" was emerging from it but did not provide additional details. Along with testing the drug in humans, the NIAID is studying the effect it had in monkeys.
In comparing two groups of rhesus macaques—one that was given remdesivir and one that was not—the group that was treated was in "significantly better health" than the untreated group. After seven days, those that were treated had lower levels of the virus in their lungs, as well as less lung damage.
Similarly to Gilead's human study, the NIAID study produced data that supported the belief that early treatment is beneficial.
Remdesivir isn't licensed and has yet to be determined to be safe or effective in treating COVID-19. Gilead is conducting another trial to determine the safety and efficacy of the five- and 10-day dosing durations for patients with moderate cases, compared with the standard of care. Those results are expected at the end of May.
