Results from a recent cohort analysis of 53 patients hospitalized with severe complications of coronavirus disease 2019 (COVID-19) showed that treatment with remdesivir, an investigational nucleotide analog with broad spectrum antiviral activity, led to clinical improvement in more than two-thirds of patients.
The analysis included patients with confirmed SARS-CoV-2 infection who had an oxygen saturation of ≤94% while breathing ambient air or who were receiving oxygen support. Of the 53 patients included in the study, 34 patients were receiving mechanical ventilation at baseline, including 4 patients on extracorporeal membrane oxygenation. Patients received remdesivir 200mg intravenously on day 1, then 100mg daily for the next 9 days for a total of 10 days of treatment.
Findings showed that 68% (n=36/53) of patients had an improvement in oxygen support over a median follow-up of 18 days from the first dose of remdesivir. Moreover, 57% of patients on mechanical ventilation were extubated (n=17/30) and 47% of all patients (n=25/53) were discharged from the hospital following treatment.
At day 28 of follow-up, clinical improvement, defined as discharge from the hospital and/or at least a 2-point improvement from baseline on a predefined 6-point scale, was reported in 84% of patients according to Kaplan-Meier analysis. Clinical improvement was observed to be less frequent in patients on invasive ventilation compared with those on noninvasive ventilation (HR 0.33; 95% CI, 0.16-0.68), and among patients >70 years of age compared with those <50 years of age (HR 0.29; 95% CI, 0.11-0.74).
Additionally, overall mortality rate was found to be 13% (n=7/53), with higher rates observed in patients on invasive ventilation (18%; n=6/34) compared with those on noninvasive oxygen support (5%; n=1/19). Increased mortality risk was associated with patients aged >70 years vs those <70 years (HR 11.34 [95% CI 1.36, 94.17]) and among those with higher baseline serum creatinine levels (HR per mg/dL: 1.91 [95% CI 1.22, 2.99]).
Limitations of the compassionate use study included small sample size, short duration of follow-up, potential missing data due to the nature of the program, and lack of a randomized control group.
Full detailed results are published in The New England Journal of Medicine.
“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
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