Respiratory failure & ventilation
Repair of Acute Respiratory Distress Syndrome in Coronavirus Disease (COVID-19) by Stromal Cells (REALIST-COVID Trial): A Multicenter, Randomized, Controlled Clinical Trial
Authors' conclusion
ORBCEL-C MSCs were safe in subjects with moderate to severe COVID-19-related ARDS but did not improve surrogates of pulmonary organ dysfunction.
Study context
- Population
- Patients with moderate to severe COVID-19-related acute respiratory distress syndrome (ARDS)
- Participants
- 30 vs 29
- Comparison
- ORBCEL-C vs placebo
- ORBCEL-Cn = 30
- Placebon = 29reference
Methodological detailsmulticentre, double-blind, allocation-concealed, placebo-controlled, 1 participant in the placebo group withdrew consent
- Multicentre
- Double-blind
- Allocation-concealed
- Placebo-controlled
- 1 participant in the placebo group withdrew consent
Primary result
As reported in the abstract
Oxygenation index (cm H2O/kPa) · Day 7
Secondary outcomes
Secondary surrogate outcomes (respiratory compliance, driving pressure, PaO2:FiO2, SOFA) and mortality at Day 28, Day 90, 1 year, 2 years
- No differences
Interstitial lung disease at 1 year and significant medical events up to 2 years
- No difference
Peripheral blood transcriptome
- ORBCEL-C modulated the peripheral blood transcriptome
Safety
Events
| Outcome | ORBCEL-C | Placebo | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| Serious adverse events (primary safety outcome) | 6 | 3 | 2.9 (0.6–13.2) | P = 0.25 | |
| 0.050.21520Relative risk (log scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Repair of Acute Respiratory Distress Syndrome in COVID-19 by Stromal Cells (REALIST-COVID Trial): A Multicenter, Randomized, Controlled Clinical Trial. Am J Respir Crit Care Med. Published 1 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →