- Observational data from an analysis of compassionate use cases hint at a moderate clinical benefit of remdesivir in patients hospitalized with severe COVID-19.
- Several randomized, clinical trials are underway/actively recruiting patients to determine therapeutic value, and these observational results are preliminary.
Why this matters
- The findings have significant limitations, precluding inferences regarding clinical value.
- 53/61 patients with postbaseline data received >1 remdesivir dose.
- 64% (34) were on mechanical ventilation (MV); 8% (4) were on extracorporeal membrane oxygenation (ECMO).
- During median 18-day follow-up (interquartile range, 13-23):
- 68% (36) had improved oxygen status.
- 15% (8) had worsened status.
- 57% (17) of MV patients were extubated.
- 75% (3/4) stopped ECMO; all were alive at last follow-up.
- At 28 days, cumulative incidence of clinical improvement (a decrease of 2+ points on a 6-point ordinal scale or live discharge) was 84% (95% CI, 70%-99%).
- 13% (7) died: 18% (6) on MV and 5% (1) on noninvasive oxygen support.
- Adverse events in 60% (32); 23% (12) serious.
- Safety, efficacy of compassionate use of remdesivir (200 mg intravenously day 1, plus 100 mg daily for 9 days), 25 January-7 March, United States, Europe, Canada, Japan.
- Funding: Gilead Sciences.
- Small sample size.
- Viral load unknown.
- Heterogeneous treatment duration.
- Data missing for 8 patients.