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

Table 2 Primary and secondary outcomes according to assigned treatment arm

Characteristic	FX06	Placebo	Estimated effect* (95% CI)	p-value
D1–D7 EVLWi variation†, mL/kg	− 1.9 [− 3.3; − 0.5]	− 0.8 [− 5.5; 1.1]	− 0.48 [− 3.2; 2.3]	0.72
EVLWi†, mL/kg
D1	15.9 [13.7; 18.3]	15.5 [12.6; 18.6]		0.38
D7	14.4 [12.3; 17.5]	12.4 [10.0; 17.2]		0.89
Survival
D7	24/25 (96)	21/24 (88)	− 8% [− 10%; 29%]^ʊ	0.35
D30	21/25 (84)	17/24 (71)	− 13% [− 37%; 11%]^ʊ	0.27
D60	17/25 (68)	17/24 (71)	+ 3% [− 24%; 30%]^ʊ	0.83
D30 respiratory support-free days‡	0 [0; 14]	9 [0; 19]	OR = 0.4 [0.1; 1.2] /IRR = 1.1 [0.8; 1.5]	0.19
D30 vasopressor-free days§	18 [12; 29]	17 [0; 30]	1 [− 15; 20]	0.90
D30 RRT-free days¶	30 [23; 30]	30 [0; 30]	0 [− 12; 9]	0.49
D30 SOFA-free days\|\|	0 [0; 0]	0 [0; 1]	OR = 0.4 [0.1; 1.5] /IRR = 1.1 [0.3; 4.4]	0.41
Plasma d-dimer, ng/L			− 358 [− 1120; 634]^ϕ	1.0
D1	2650 [1029; 8348]	2625 [1335; 4872]
D7	3190 [1691; 8360]	2270 [1339.5; 3544]
Serum C-reactive protein, mg/L			− 48 [− 118; 53]^ϕ	0.90
D1	102 [57.8; 159]	120 [79; 215]
D7	124 [87; 185]	140 [79; 193]
Plasma IL-6**, pg/mL			29 [− 125; 115]^ϕ	0.91
D1	24.9 [15.5; 93.6]	23.4 [3.85; 42.1]
D7	118.2 [41.8; 218.7]	25.2 [14.9; 153.3]
Plasma IL-10**, pg/mL			0 [− 188; 6]^ϕ	0.93
D1	0.2 [0; 34.9]	2.1 [0; 52.6]
D7	8.1 [0; 25.7]	0.5 [0; 69.0]
Plasma sVE-cadherin**, ng/mL			38 [− 170; 195]^ϕ	0.57
D1	586.3 [540.1; 681.6]	473.5 [393.1; 570.9]
D7	628.7 [569.4; 793.1]	676.6 [580.5; 692.1]

Values are expressed as n (%) or median [25th; 75th percentiles, IQR]. D day. *Between-group difference of the mean variation of extravascular lung-water index (EVLWi) from day 1 to day 7, adjusted to the initial EVLWi. †Extravascular lung-water indexed to the predicted body weight. ‡Number of days alive without invasive mechanical ventilation. The effect estimate from Hurdle model is odds ratio to have more than 0 days alive without invasive mechanical ventilation/incidence risk ratio and bootstrap 95% CI. §Number of days alive without vasopressors. The effect estimate was measured with a median difference between arms and bootstrap 95% CI. ¶Number of days alive without renal replacement therapy. The effect estimate was measured with a median difference between arms and bootstrap 95% CI. ||Number of days alive without organ failure, defined by one or more Sequential Organ-Failure sub-Scores ≥ 3. The effect estimate obtained from Hurdle model is incidence risk ratio to have more than 0 days alive without organ failure/incidence risk ratio and bootstrap 95% CI. **Available for 13 FX06 recipients and 11 controls. ^ʊthe effect estimate was measured with a difference of proportion between arms and its exact binomial 95% confidence interval. ^ϕThe effect estimate was measured as a median difference of change from baseline between arms and bootstrap 95% CI

ISSN: 1364-8535