FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial - Institut de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition Access content directly
Journal Articles Critical Care Year : 2023

FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial

Abstract

Background: Vascular leakage is a major feature of acute respiratory distress syndrome (ARDS). We aimed to evaluate the efficacy of FX06, a drug under development that stabilizes interendothelial cell junctions, at reducing vascular leakage during SARS-CoV-2-induced ARDS. Methods: This multicenter, double-blinded, randomized trial included adults with COVID-19-associated ARDS who had received invasive mechanical ventilation for < 5 days and were randomized to receive either intravenous FX06 (400 mg/d, for 5 days) or its vehicle as placebo. The primary endpoint was the lowering—from day 1 to day 7—of the transpulmonary thermodilution-derived extravascular lung-water index (EVLWi). Results: Twenty-five patients were randomized to receive FX06 and 24 the placebo. Although EVLWi was elevated at baseline (median [IQR] 15.6 mL/kg [13.5; 18.5]), its declines from day 1 to day 7 were comparable for FX06 recipients and controls (respectively, − 1.9 [− 3.3; − 0.5] vs. − 0.8 [− 5.5; − 1.1] mL/kg; estimated effect − 0.8 [− 3.1; + 2.4], p = 0.51). Cardiac indexes, pulmonary vascular permeability indexes, and fluid balances were also comparable, as were PaO2/FiO2 ratios and durations of mechanical ventilation. Adverse event rates were similar for the 2 groups, although more FX06 recipients developed ventilator-associated pneumonia (16/25 (64%) vs. 6/24 (24%), p = 0.009). Conclusions: In this unique-dosing–regimen study, FX06 did not lower SARS-CoV-2-induced pulmonary vascular leakage. Future investigations will need to evaluate its efficacy at earlier times during the disease or using other regimens. Trial registration NCT04618042. Registered 5 November 2020.
Fichier principal
Vignette du fichier
s13054-023-04616-1.pdf (1.04 Mo) Télécharger le fichier
Origin : Publisher files allowed on an open archive
licence : CC BY - Attribution

Dates and versions

hal-04229512 , version 1 (24-10-2023)

Licence

Attribution

Identifiers

Cite

Emmanuelle Guérin, Lisa Belin, Guillaume Franchineau, Loïc Le Guennec, David Hajage, et al.. FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial. Critical Care, 2023, 27 (1), pp.331. ⟨10.1186/s13054-023-04616-1⟩. ⟨hal-04229512⟩
69 View
7 Download

Altmetric

Share

Gmail Facebook X LinkedIn More