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.
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