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This is not a randomized controlled trial. It's a publication summarizing results of 53 #COVIDー19 patients given #remdesivir (compassionate-use). Clinical improvement observed in 36 / 53 (68%). Randomized, placebo-controlled trials should be done next. nejm.org/doi/full/10.10…
Patients were enrolled in the United States (22 patients), Japan (9), Italy (12), Austria (1), France (4), Germany (2), Netherlands (1), Spain (1), Canada (1). At baseline, majority of patients were receiving invasive ventilation, 57% receiving mechanical ventilation, 8% ECMO.
For each oxygen-support category, percentages were calculated with the number of #COVIDー19 patients at baseline as the denominator. Improvement (blue cells), no change (beige) and worsening (gray) in oxygen-support status are shown.
Cumulative Incidence of Clinical Improvement from Baseline to Day 36. #COVIDー19 #remdesivir
Cumulative Incidence of Clinical Improvement from Baseline to Day 36. #COVIDー19 #remdesivir
Cumulative Incidence of Clinical Improvement from Baseline to Day 36. #COVID19 #remdesivir
32 patients (60%) reported adverse events. Most common adverse events: increased hepatic enzymes, diarrhea, rash, renal impairment, hypotension. Adverse events were more common in patients receiving invasive ventilation. A total of 12 patients (23%) had serious adverse events.
The compassionate-use program did not collect viral load data to confirm the antiviral effects of #remdesivir. Duration of therapy was not uniform in the study, largely because clinical improvement enabled discharge from the hospital. #COVIDー19
No new safety signals were detected during short-term #remdesivir therapy in the #COVIDー19 cohort. Interpretation of the results is limited by the small size of the cohort, relatively short duration of follow-up, potential missing data owing to the nature of the program.
Other factors may have contributed to differences in outcomes: supportive care, differences in institutional #COVID19 treatment protocols, thresholds for hospitalization. Invasive ventilation as a proxy for disease severity may be influenced by availability of #ventilators.
Findings from this compassionate-program study will be informed by the ongoing randomized placebo-controlled trials of #remdesivir for #COVIDー19. This looks hopeful but until we see data from a randomized controlled trial, we should not change clinical practice guidelines.
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