In a report published in the New England Journal of Medicine, researchers confirm the benefits of the drug Remdesivir, used for treating patients hospitalized for COVID-19.
The drug was initially given emergency use authorization (EUA) in May by the FDA for use in patients requiring oxygen or ventilation, however, the agency gave an expanded EUA to the drug in August following studies showing that benefits of using the drug on even moderately ill patients outweigh the risks.
It is used for its ability to hinder the virus's ability to reproduce, and has been attributed to shorter hospital stays for patients given the drug in trials.
In the report, researchers led by a team at the National Institute of Allergy and Infectious Diseases released final data on a study that began in May.
A total of 1,062 patients that had evidence of lower respiratory tract infection were recruited for the study. The participants were broken in two groups: one consisted of 541 patients received the drug, and the second consisted of the remaining 521 who received a placebo.
Patients were assessed daily during their hospitalization, from day 1 through day 29. Day 15 was initially used to compare clinical status, however a change was made for a comparison of time to recovery by day 29 in response to evolving information, external to the trial, indicating that COVID-19 may have a more protracted course than previously anticipated.
The report states that throughout the duration of the trial, numerous challenges were encountered as the coronavirus inhibited normal movement and practices. Results showed that those who received Remdesivir have a median recovery time of ten days, compared with 15 days among the placebo group.
The mortality rate among Remdesivir patients was also lower: an estimated mortality rate of 6.7% was attributed to the Remdesivir group at day 15 compared to 11.9% among the placebo group, and 11.4% with Remdesivir compared to 15.2% treated with the placebo by day 29.
Moreover, adverse events were reported in only 131 of the 532 patients who received Remdesivir (24.6%) compared to 163 of the 516 patients who received placebo (31.6%).
Ultimately, data from the report showed that "Remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection."
The mean age of the patients was close to 59 years of age, and 64.4% of which were male. On the basis of the evolving epidemiology of COVID-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia. Overall, 53.3% of the patients were White, 21.3% were Black, 12.7% were Asian and 12.7% were designated as other or not reported; 250 (23.5%) were Hispanic or Latino.
Most patients had at least one of the pre-specified coexisting conditions at enrollment, most commonly hypertension (50.2%), obesity (44.8%) and type 2 diabetes mellitus (30.3%).
Enrollment for the "Adaptive COVID-19 Treatment Trial 1" began February 21, 2020 and ended April 19. There were 60 trial sites and 13 sub-sites worldwide, 45 of which were in the US, eight in Denmark, five in the United Kingdom, four in Greece, three in Germany, two each in Korea and Spain, and one each in Japan and Singapore.
Challenges during the study included "restricted travel and hospitals restricting the entrance of nonessential personnel. Training, site initiation visits, and monitoring visits often were performed remotely. Research staff were often assigned other clinical duties, and staff illnesses strained research resources. Many sites did not have adequate supplies of personal protective equipment and trial-related supplies, such as swabs."
Despite hardships however, "research teams were motivated to find creative solutions to overcome challenges."