COVID-19: hints at remdesivir benefit in small observational study

  • Grein J & al.
  • N Engl J Med
  • 10 Apr 2020

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • 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.

Key results

  • 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.

Study design

  • 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.

Limitations

  • Small sample size.
  • Observational. 
  • Viral load unknown.
  • Heterogeneous treatment duration.
  • Data missing for 8 patients.