COVID-19: clinical improvement with remdesivir, but relevance is unclear

  • Spinner CD & al.
  • JAMA
  • 21 ago. 2020

  • de Liz Scherer
  • Clinical Essentials
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

Takeaway

  • A 5-day course of remdesivir appears to yield better clinical status vs standard care in patients hospitalized with moderate COVID-19 pneumonia, but the clinical relevance is unclear.

Why this matters

  • Remdesivir may provide modest clinical benefit in patients hospitalized with moderate COVID-19 pneumonia.
  • Important questions remain, including optimal patient population, therapy duration, and potential for drug-drug interactions with concomitant corticosteroids.

Key results

  • 584 patients (10-day remdesivir: n=193; 5-day: n=191; standard care: n=200).
  • Comorbidities: cardiovascular disease (56%), hypertension (42%), diabetes (40%), asthma (14%).
  • Day 11: 5-day remedesivir was linked to significantly higher odds of better clinical status vs standard care:
    • OR, 1.65 (P=.02).
  • No significant difference noted for 10-day remdesivir vs standard care (P=.18).
  • No differences observed for any exploratory clinical status endpoints between 5- or 10-day remdesivir vs standard care.
  • Day 28, 9 patients had died:
    • 5-day remdesivir, 1% (n=2; log-rank P=.43).
    • 10-day, 2% (n=3; log-rank P=.72).
    • Standard care, 2% (n=4; 95% CI, 0.1%-4.1%).
  • Adverse events: more common in treatment groups (5%) vs standard care (9%), included nausea, hypokalemia, headache.

Study design

  • Prospective randomized, open-label, multicenter evaluation of 5- and 10-day remdesivir regimen vs standard care in patients hospitalized with moderate COVID-19 pneumonia.
  • Funding: Gilead Sciences.

Limitations

  • Primary endpoint changes.
  • Open label.
  • Virologic outcomes, laboratory parameters unanalyzed.
  • Ordinal scale used for outcomes evaluation.