A new study found patients hospitalized with severe complications of COVID-19 demonstrated significant clinical improvement with remdesivir treatment.
Results from a cohort analysis of patients hospitalized with severe complications of coronavirus disease 2019 (COVID-19) showed that most participants who received remdesivir on a compassionate-use basis demonstrated clinical improvement and no new safety signals were identified.
The results of the study, funded by Gilead Sciences, were published April 10, 2020 in the New England Journal of Medicine.
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful," said lead author Jonathan D. Grein, MD, director of hospital epidemiology, Cedars-Sinai Medical Center, Los Angeles, in a Gilead press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
The cohort evaluated data from 53 patients in the US, Europe, Canada, and Japan with confirmed SARS-CoV-2 infection who had an oxygen saturation of ≤94% while breathing ambient air or who were receiving oxygen support.
At baseline, 30 patients (57%) were on mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.
Between January 25, 2020 and March 7, 2020, patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on the first day and then 100 mg daily for the remaining 9 days of treatment.
Remdesivir Treatment Shows Promise
During a median follow-up of 18 days from the first dose of remdesivir, 36 patients (68%) had improvement in oxygen support class. Approximately 57% of patients on mechanical ventilation were extubated and 47% were discharged from the hospital following treatment.
The overall mortality rate was 13% and was higher in the subgroup of patients on invasive ventilation (18%) vs those on noninvasive oxygen support (5%). Higher baseline serum creatinine levels and age >70 years were associated with an increased risk of mortality.
The researchers did note that the interpretation of these results is limited by the small cohort size, the short duration of follow-up, potential missing data due to the nature of the program, and lack of a randomized control group.
Because of these limitations, data from ongoing, randomized clinical trials of remdesivir are needed to give a more robust understanding of the drug’s clinical impact.
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