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Table 2  Demographics and baseline characteristics

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

Parameter

Normal reference range [37,38,39,40,41,42,43]

sCAP patients (phase II CIGMA) N = 160

Healthy subjects (phase I) N = 24

p-valuea

Male, n (%)

n/a

113 (70.6)

10 (41.7)

n/d

Race, n (%)

 Caucasian

n/a

154 (96.3)

22 (91.7)

n/d

 African

4 (2.5)

0

 Asian

1 (0.6)

2 (8.3)

 Other (Latin/Hispanic)

1 (0.6)

0

Country, n (%)

 Germany

n/a

38 (23.8)

24 (100)

n/d

 Spain

108 (67.5)

0

 UK

14 (8.8)

0

Age (years), mean (SD)

n/a

65 (15)

30 (7)

n/d

BMI (kg/m2), mean (SD)

n/a

26.2 (4.9)

23.6 (3.2)

n/d

IgM (g/L)

 n

0.4–2.3 [41]

160

24

 < 0.001

 Median (IQR)

0.57 (0.38–0.88)

1.0 (0.8–1.4)

IgG (g/L)

 n

7–16 [41]

160

24

 < 0.001

 Median (IQR)

6.6 (4.6–8.7)

9.9 (8.5–12.4)

IgA (g/L)

 n

0.7–4.0 [41]

160

24

0.360

 Median (IQR)

2.1 (1.4–3.2)

2.0 (1.6–2.5)

Neutrophils (109/L)

 n

2.5–8.0 [37]

150

24

 < 0.001

 Median (IQR)

11.5 (6.0–17.1)

3.7 (3.2–4.7)

Lymphocytes (109/L)

 n

1.0–4.0 [37]

150

24

 < 0.001

 Median (IQR)

0.69 (0.42–1.0)

1.6 (1.3–2.3)

NLR

 n

0.8–3.5 [42]

149

24

 < 0.001

 Median (IQR)

16.1 (8.3–27.3)

2.1 (1.5–3.1)

Monocytes (109/L)

 n

0.1–0.7 [37]

155

24

0.468

 Median (IQR)

0.51 (0.23–0.90)

0.44 (0.35–0.56)

Platelets (109/L)

 n

150–450[[43]]

160

24

0.516

 Median (IQR)

202 (149–277)

225 (182–259)

CRP (mg/L)

 n

0–10 [40]

155

24

 < 0.001

 Median (IQR)

230 (113–333)

0.1 (0.1–0.2)

PCT (µg/L)

 n

 ≤ 0.10 [39]

145

n/d

n/d

 Median (IQR)

5.1 (0.91–20.5)

Albumin (g/L)

 n

35–55 [43]

125

24

 < 0.001

 Median (IQR)

27.0 (24.1–31.0)

47.0 (46.0–50.0)

  1. BMI body mass index, CRP C-reactive protein, Ig immunoglobulin, IQR interquartile range, NLR neutrophil-to-lymphocyte ratio, PCT procalcitonin, sCAP severe community-acquired pneumonia, SD standard deviation, n/a not applicable, n/d not determined, UK United Kingdom
  2. aThe Shapiro–Wilk normality test did not show a normal distribution for any of the laboratory parameters measured in sCAP patients and for some of the parameters measured in healthy subjects (CRP, IgM, and monocytes). Accordingly, unpaired, nonparametric Mann–Whitney testing was performed to determine the differences between sCAP and healthy subjects for all parameters