Although a study suggests that patients may show a clinical improvement when receiving a 5-day course of remdesivir, investigators said this is of uncertain clinical significance.
Patients with coronavirus disease 2019 (COVID-19) may have a better clinical status when receiving a 5-day course of remdesivir, compared with patients who receive the standard of care, according to a new study published by JAMA.
As a nucleotide prodrug that inhibits viral RNA-dependent RNA polymerases, remdesivir has shown some clinical benefit in studies investigating patients with severe COVID-19. Despite ongoing research continuing this line of investigation, the authors noted that remdesivir’s efficacy in patients with moderate COVID-19 is still unknown.
In order to investigate this, researchers compared the efficacy of a 5-day course of remdesivir, 10-day course of remdesivir, and standard of care on the eleventh day following initiation of treatment. The study was conducted between March 15 and April 18, 2020, at 105 hospitals with patients with confirmed moderate COVID-19 pneumonia. The final follow-up was May 20.
In the study, 197 patients received a 10-day course of remdesivir, 199 received a 5-day course, and 200 received the standard of care. Patients receiving remdesivir were given 200 mg intravenously on day 1 followed by 100 mg per day.
Of the 596 patients who began the study, 533 completed it. Patients had a median age of 57 and were 39% female, 56% had cardiovascular disease, 42% had hypertension, and 40% had diabetes. The median length of treatment was 5 days for those in the 5-day course group, and 6 days for those randomized to the 10-day course.
On day 11, the researchers found that patients in the 5-day group had statistically significantly higher odds of a better clinical status distribution than those receiving standard of care. The clinical status distribution between the 10-day course group and the standard of care group was not statistically different. Nine patients had died by day 28, including 2 in the 5-day remdesivir group, 3 in the 10-day group, and 4 in the standard care group.
The investigators noted that nausea (10% vs 3%), hypokelamia (6% vs 2%), and headache (5%vs 3%) were more frequent among remdesivir-treated patients compared with standard care patients.
Based on these findings, the researchers said that patients receiving a 5-day course of remdesivir may show clinical improvements compared with those who receive longer courses or the standard care. However, the investigators said this difference is of uncertain clinical importance and further research is needed.
Spinner C, Gottlieb R, Criner G, et al. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19. JAMA; August 21, 2020. https://jamanetwork.com/journals/jama/fullarticle/2769871?guestAccessKey=82e07e86-0461-4065-b286-05aa2cec402a&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=082120. Accessed August 26, 2020.