Respiratory failure & ventilation
FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial
Primary result · Change in EVLWiResult — go to the resultEstimated effect - 0.8 CI - 3.1; + 2.4Authors' conclusion
In this unique-dosing-regimen study, FX06 did not lower SARS-CoV-2-induced pulmonary vascular leakage.
Study context
- Population
- Adults with COVID-19-associated acute respiratory distress syndrome (ARDS) on invasive mechanical ventilation for < 5 days
- Participants
- 25 vs 24
- Comparison
- IV FX06 vs vehicle placebo
- FX06n = 25
- Placebon = 24reference
- Primary endpoint
- Lowering of transpulmonary thermodilution-derived extravascular lung-water index (EVLWi)
- Follow-up
- Day 1 to day 7
Methodological detailsmulticentre, double-blinded, placebo-controlled
- Multicentre
- Double-blinded
- Placebo-controlled
Primary result
Change in EVLWi
Estimated effect
- 0.8
CI - 3.1; + 2.4
P = 0.51
Change by group
FX06
- 1.9
median · IQR - 3.3; - 0.5 · mL/kg
Placebo
- 0.8
median · IQR - 5.5; - 1.1 · mL/kg
As reported in the abstract
Further findings
Cardiac indexes, pulmonary vascular permeability indexes, fluid balances, PaO2/FiO2 ratios, duration of mechanical ventilation
- Comparable between groups
Safety
VAP
P = 0.009
Adverse events
- Adverse event rates similar for the 2 groups
Original publication
FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial. Crit Care. Published 29 August 2023. doi:10.
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