The immunomodulating activity of trimodulin (polyvalent IgM, IgA, IgG solution): a post hoc analysis of the phase II CIGMA trial

Table 3 Ventilator-free days in patients treated with trimodulin or placebo

Subgroup	Number of patients (% of total per arm)	Ventilator-free days		p-value*
Subgroup	Number of patients (% of total per arm)	Placebo Median [IQR]	Trimodulin Median [IQR]	p-value*
All	P: 79 (100%) T: 81 (100%)	8.0 [0, 19.0]	11.0 [0, 20.0]	0.173^a
CRP^high	P: 59 (74.7%) T: 65 (80.2%)	4.0 [0, 19.0]	14.0 [0, 20.0]	0.043^a
IgM^low	P: 55 (69.6%) T: 56 (69.1%)	7.0 [0, 19.0]	15.0 [0.25, 20.0]	0.029^a
ALC^low	P: 56 (70.9%) T: 55 (67.9%)	3.5 [0, 18.8]	11 [0, 19.0]	0.043
CRP^high NLR^high	P: 23 (29.1%) T: 29 (35.8%)	12.0 [0, 19.0]	15.0 [5, 21.0]	0.148
CRP^high + ALC^low	P: 44 (55.7%) T: 46 (56.8%)	3.5 (0, 18.8]	11.5 [0, 20.0]	0.046
CRP^high + IgM^low	P: 41 (51.9%) T: 51 (63.0%)	4.0 [0, 19.0]	15.0 [1.0, 20.0]	0.059^a
NLR^high + IgM^low	P: 23 (29.1%) T: 24 (29.6%)	7.0 [0, 19.0]	16.0 [9.0, 19.8]	0.057
ALC^low + IgM^low	P: 41 (51.9%) T: 37 (45.7%)	3.0 [0, 18.0]	15.0 [4.5, 19.5]	0.009

ALC absolute lymphocyte count, CRP C-reactive protein, IQR interquartile range, NLR neutrophil-to-lymphocyte ratio, P placebo, T trimodulin
*One-sided Mann–Whitney test. The significance level is p < 0.025 (indicated in bold)
^aPreviously published data from the CIGMA trial [12]. Here, the p-value was calculated with a one-sided Wilcoxon rank sum test with continuity correction (0.5) and a significance level of 0.025

ISSN: 1364-8535