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Table 1 Characteristics of the patients at baseline according to allocated treatment

From: Efficacy and safety of the investigational complement C5 inhibitor zilucoplan in patients hospitalized with COVID-19: an open-label randomized controlled trial

 

Zilucoplan

Control

All patients

 

N = 54

N = 24

N = 78

Male sex—no. (%)

49 (91)

19 (79)

68 (87)

Ethnicity—no. (%)

   

 African

4 (7)

0

4 (5)

 Arabian

3 (6)

1 (4)

4 (5)

 Asian

1 (2)

0

1 (1)

 Caucasian

46 (85)

22 (92)

68 (87)

 Other

0

1 (4)

1 (1)

Age at baseline—median (min, max), years

63 (35, 83)

64 (50, 85)

63 (35, 85)

BMI—mean (SD)

28 (4)

30 (4)

29(4)

Co-existing conditions—no. (%)

   

 Arterial hypertension

26 (48)

10 (42)

36 (46)

 Diabetes mellitus

14 (26)

4 (17)

18 (23)

 Cardiovascular disease

9 (17)

10 (42)

19 (24)

 Chronic kidney disease

4 (7)

0

4 (5)

6-point ordinal scale at baseline—no. (%)

   

 2 Invasive mechanical ventilation

8 (15)

2 (8)

10 (13)

 3 Non-invasive ventilation or high flow oxygen devices

19 (35)

8 (33)

27 (35)

 4 Hospitalized, requiring supplemental oxygen

26 (48)

14 (58)

40 (51)

 5 Hospitalized, not requiring supplemental oxygen

1 (2)

0

1 (1)

Admitted to ICU at randomisation—no. (%)

30 (56)

12 (50)

42 (54)

Days of symptoms at randomisation—median (min, max)

10 (7, 16)

10 (6, 13)

10 (6, 16)

Days of hospitalization at randomisation—median (min, max)

3 (1, 8)

2 (1, 11)

2 (1, 11)

PaO2/FiO2 ratio at baseline—mean (SD), mmHg

169 (94)

175 (93)

171 (93)

A-a gradient at baseline—mean (SD), mmHg

272 (211)

237 (208)

261 (209)

SOFA score at baseline—no. (%)

   

 1–2

29 (57)

14 (61)

43 (58)

 3–4

14 (28)

7 (30)

21 (28)

 5–6

1 (2)

2 (9)

3 (4)

 7–8

7 (14)

0

7 (10)

 Not done

3

1

4

Laboratory values at baseline—mean (SD)

   

 CRP (mg/L)

142 (89)

135 (61)

140 (81)

 Lymphocyte count (109/L)

0.9 (0.8)

0.7 (0.4)

0.8 (0.7)

 Ferritin (µg/L)

2608 (1792)

2258 (1206)

2500 (1635)

 D-dimers (ng/mL)

1100 (894)

1249 (1338)

1147 (1046)

 LDH (IU/L)

479 (178)

492 (167)

483 (174)

 C5 (µg/L)

114 (24)

98 (25)

110 (25)

Concomitant medication—no. (%)

   

 Glucocorticoids (at randomisation)

49 (91)

18 (75)

67 (86)

 Glucocorticoid use (during first 28 days)

49 (91)

18 (75)

67 (86)

 Anticoagulants (at randomisation)

50 (93)

22 (92)

72 (92)

 Antibiotics (at randomisation)

16 (30)

2 (8)

18 (23)

 Remdesivir (at randomisation)

7 (13)

2 (8)

9 (12)

  1. Body mass index (BMI) was calculated as weight in kilograms divided by height in meters squared. Sex and ethnicity were reported by study participant. SD standard deviation, CRP C-reactive protein, LDH lactate dehydrogenase, C5 complement 5, SOFA severity of organ failure assessment, PaO2 partial pressure of arterial oxygen, FiO2 fraction of inspired oxygen