The following is a summary of “FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial,” published in the August 2023 issue of Critical Care by Guérin et al.

Researchers conducted a retrospective study to evaluate the efficacy of FX06 to reduce vascular leakage in SARS-CoV-2-induced acute respiratory distress syndrome (ARDS).

They initiated a multicenter, double-blinded, randomized study involving adult patients experiencing COVID-19-related ARDS. Those with < 5 days of invasive mechanical ventilation were randomly assigned to either intravenous FX06 (400 mg/day, for five days) or a placebo vehicle. The primary aim was to decrease the transpulmonary thermodilution-derived extravascular lung-water index (EVLWi) from day 1 to day 7.

The results indicated that among the participants, 25 were assigned to FX06, while 24 received the placebo. The initial EVLWi was high (median [IQR] 15.6 mL/kg [13.5; 18.5]), and the day 1 to day 7 reductions were similar for both FX06 users and controls. Specifically, it decreased by −1.9 [−3.3; −0.5] mL/kg for FX06 recipients and by −0.8 [−5.5; −1.1] mL/kg for controls, with an estimated effect of −0.8 [−3.1; +2.4], yielding a p-value of 0.51. Similar results were seen in cardiac indexes, pulmonary vascular permeability indexes, fluid balances, PaO₂/FiO₂ ratios, and mechanical ventilation durations. The incidence of adverse events was alike in both groups, though more FX06 users experienced ventilator-associated pneumonia (16/25 (64%) vs. 6/24 (24%), P=0.009).

They concluded that FX06 did not lower SARS-CoV-2-induced pulmonary vascular leakage in this study.

Source: ccforum.biomedcentral.com/articles/10.1186/s13054-023-04616-1