Losartan with add-on spironolactone for severe COVID-19 in the intensive care unit: a randomized controlled trial.
Pierre Simeone, Julien Carvelli, Jeanne Morel et al.
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In 30 seconds
This randomized, open-label, parallel-group trial at five intensive care units in Marseille evaluated losartan, with conditional spironolactone, added to standard care for adults with severe COVID-19-related respiratory distress. Seventy-eight patients were randomized to 10 days of the experimental regimen or standard care alone. The primary outcome, day-7 SOFA score, did not differ significantly between groups: median scores were 3 versus 2 (p = 0.5). The trial also found no significant differences in intubation, duration of mechanical ventilation, 90-day mortality, adverse events, viral replication, or oxygenation.
Key findings
- Median day-7 SOFA scores were 3 in the control group and 2 in the experimental group (p = 0.5).
- No significant group differences were found in intubation rates, mechanical ventilation duration, or 90-day mortality.
- Viral replication, oxygenation parameters, and adverse events were similar between groups.
Why it matters
The trial tested whether targeting the renin-angiotensin system with losartan and conditional spironolactone could improve outcomes in critically ill patients with COVID-19. It did not detect a clinical benefit, so the findings do not establish this regimen as an effective addition to supportive care. The results are relevant to interpreting proposed pharmacological strategies for severe COVID-19, while accounting for the study’s limited power.
What to keep in mind
The trial was underpowered because it was terminated early. The primary outcome was analysed in 73 patients, fewer than the 78 randomized.