Primary outcome
EVLWi
SECONDARY
The primary outcome of EVLWi change between days 1 and 7 did not differ between FX06-treated patients and controls (Fig. Primary outcome: extravascular lung-water index (EVLWi) variations from day 1 to day 7 for FX06 recipients and placebo controls. The panels show Tukey’s boxplot visualizationPrimary and secondary outcomes according to assigned treatment armOR = 0.4 [0.1; 1.2]/IRR = 1.1 [0.8; 1.5]OR = 0.4 [0.1; 1.5]/IRR = 1.1 [0.3; 4.4]Values are expressed as Several sensitivity analyses were computed: analyzing the primary outcome for patients with ECMO vs without; most severely ill (EVLWi > 16 mL/kg) vs less severely ill; or indexing the dose received above vs below 4.2 mg/kg/d (median dose received). All failed to detect any significant FX06 effect on EVLWi (not shown). Interestingly, EVLWi measured before and 3 h after FX06 bolus injections was very similar (median variation − 0.02 [IQR − 0.57; 0.55], 