Respiratory failure & ventilation
A Randomized Trial of Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome from Coronavirus Disease (COVID-19)
Primary resultResult — go to the resultRelative risk 0.88 95% CI 0.64–1.21Authors' conclusion
Mesenchymal cells, while safe, did not improve 30-day survival or 60-day ventilator-free days in patients with moderate and/or severe COVID-19-related acute respiratory distress syndrome.
Study context
- Population
- Mechanically ventilated patients with moderate or severe COVID-19-induced ARDSof planned 300
- Participants
- 222 participants
- Comparison
- Cell vs Control
- Celln = 112
- Controln = 110reference
- Primary endpoint
- Mortality
- Follow-up
- 30 days
Methodological detailssham-controlled, prespecified interim analysis, DSMB recommended halting enrollment at the third interim analysis (n = 222 of planned 300)
- Sham-controlled
- Prespecified interim analysis
- DSMB recommended halting enrollment at the third interim analysis (n = 222 of planned 300)
Primary result
As reported in the abstract
Relative risk
0.88
95% CI 0.64–1.21
P = 0.43
Events by treatment group
Cell vs Control
RR 0.88 (95% CI 0.64–1.21); P = 0.43
Secondary outcomes
| Outcome | Control | OR for resolution or improvement of ARDS (95% CI) | |
|---|---|---|---|
| Resolution or improvement of ARDS · 30 daysCells vs Control | 43.4% | 1.36 (0.57–3.21) | |
| 0.20.5125OR for resolution or improvement of ARDS (log scale) |
| Outcome | Control |
|---|---|
| Days alive off ventilation within 60 days (ranked analysis; higher is better) | median rank 102.0 (IQR 54.0–162.5) |
- Days alive off ventilation within 60 days (ranked analysis; higher is better): Cells median rank 117.3 (IQR 60.0–169.5)
- Resolution or improvement of ARDS: Cells 49.0%
- Resolution or improvement of ARDS: 51/104 vs 46/106
Days alive off ventilation within 60 days (ranked analysis; higher is better)
- No significant differences
Safety
Infusion-related toxicities; serious adverse events over 30 days
- No infusion-related toxicities
- Overall serious adverse events similar
Original publication
A Randomized Trial of Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome from COVID-19. Am J Respir Crit Care Med. Published 1 February 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →