Respiratory failure & ventilation
Angiotensin-(1–7) infusion in COVID-19 patients admitted to the intensive care units (ICU): a seamless phase 1–2 randomized clinical trial
- prematurely stopped due to low recruitment rate
- Between August 2020 and July 2021; stopped prematurely due to low recruitment rate
Authors' conclusion
The main findings of our study indicate that continuous intravenous infusion of Angiotensin-(1-7) at 10 mcg/Kg day in COVID-19 patients admitted to the ICU with severe pneumonia is safe.
Study context
- Population
- COVID-19 patients admitted to the ICU28 Phase 1, 79 Phase 2
- Comparison
- IV Angiotensin- plus standard of care vs controls
- Primary endpoint
- Phase 2: number of oxygen free days (OFDs); Phase 1: rate of serious adverse events (SAEs)
- Follow-up
- Day 28
Methodological detailsinvestigator-initiated, Phase 1 open label, Phase 2 double-blind, two ICUs
- Investigator-initiated
- Phase 1 open label
- Phase 2 double-blind
- Two ICUs
Primary result
As reported in the abstract
OFDs (Phase 2)
P = 0.15
Further findings
| Outcome | Absolute difference (days) (95% CI) | P value |
|---|---|---|
| OFDs, pooled Phase 1-2 intention to treat analysisSignificantly higher in treated patients · pooled intention to treat | −5 (0–7) | P = 0.04 |
Safety
- Serious adverse events (SAEs) possibly related to infusion (Phase 1) — Angiotensin-(1-7)
- 1 events
- SAEs possibly related to infusion (Phase 1) — Bradycardia, justifying discontinuation of the infusion
- 1
Original publication
Angiotensin-(1–7) infusion in COVID-19 patients admitted to the ICU: a seamless phase 1–2 randomized clinical trial. Ann Intensive Care. Published 4 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →