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Table 1 Demographics and patient characteristics at baseline (safety population)

From: Immunomodulatory and clinical effects of receptor-interacting protein kinase 1 (RIPK1) inhibitor eclitasertib (SAR443122) in patients with severe COVID-19: a phase 1b, randomized, double-blinded, placebo-controlled study

 

Placebo

(N = 20)

Eclitasertib 600 mg

(N = 47)

All

(N = 67)

Age (years), mean (SD)

55.2 (13.5)

58.9 (11.3)

57.8 (12.0)

Sex, n(%)

   

 Male / Female

12 (60.0)/ 8 (40.0)

28 (59.6)/ 19 (40.4)

40 (59.7)/ 27 (40.3)

Race, n(%)

   

 White

16 (80.0)

40 (85.1)

56 (83.6)

 Black or African American

2 (10.0)

3 (6.4)

5 (7.5)

 American Indian or Alaska Native

1 (5.0)

1 (2.1)

2 (3.0)

 Unknown

1 (5.0)

2 (4.3)

3 (4.5)

 Multiple

0

1 (2.1)

1 (1.5)

 American Indian or Alaska Native/White

0

1 (2.1)

1 (1.5)

Ethnicity, n (%)

   

 Hispanic or Latino

13 (65.0)

30 (63.8)

43 (64.2)

 Not Hispanic or Latino

6 (30.0)

14 (29.8)

20 (29.9)

 Not Reported

1 (5.0)

1 (2.1)

2 (3.0)

 Unknown

0

2 (4.3)

2 (3.0)

Baseline weight (kg), mean (SD)

88.9 (19.3)

89.1 (19.7)

89.1 (19.4)

BMI (kg/m2), n(%)

   

 18.5 to < 25

2 (10.0)

6 (12.8)

8 (11.9)

 25 to < 30

8 (40.0)

20 (42.6)

28 (41.8)

 30 to < 40

9 (45.0)

13 (27.7)

22 (32.8)

 ≥ 40

1 (5.0)

8 (17.0)

9 (13.4)

Medical history group, n (%)

   

 Obesity

10 (50.0)

22 (46.8)

32 (47.8)

 Diabetes

4 (20.0)

17 (36.2)

21 (31.3)

 Respiratory disorders

4 (20.0)

8 (17.0)

12 (17.9)

 Renal disorders

1 (5.0)

7 (14.9)

8 (11.9)

 Cardiovascular disorders

2 (10.0)

4 (8.5)

6 (9.0)

 Autoimmune disorders

2 (10.0)

1 (2.1)

3 (4.5)

Days since COVID-19 diagnosis, mean (SD)

7.7 (3.8)

8.0 (4.9)

7.9 (4.5)

Days since COVID-19 hospitalisation, mean (SD)

3.1 (2.8)

2.8 (1.5)

2.9 (2.0)

ICU admission at baseline

   

 No / Yes

17 (85.0)/ 3 (15.0)

46 (97.9)/ 1 (2.1)

63 (94.0)/ 4 (6.0)

Baseline CRP (mg/L), mean (SD)

133.5 (88.4)

105.6 (67.2)

113.9 (74.6)

Baseline Ferritin (ug/L), mean (SD)*

1411.1 (1086.9)

2389.0 (8126.6)

2089.3 (6784.3)

Baseline LDH (IU/L), mean (SD)*

338.4 (116.0)

350.8 (111.4)

347.0 (112.0)

Baseline SpO2/FiO2(ratio), mean (SD)

294.1 (55.3)

296.8 (62.9)

296.0 (60.3)

Oxygen therapy at baseline

   

 Nasal cannula

13 (65.0)

25 (53.2)

38 (56.7)

 Simple face mask

6 (30.0)

17 (36.2)

23 (34.3)

 Non-rebreather face mask

0

1 (2.1)

1 (1.5)

 High-flow nasal cannula

1 (5.0)

1 (2.1)

2 (3.0)

 Non-invasive ventilation

0

1 (2.1)

1 (1.5)

 Ambient

0

2 (4.3)

2 (3.0)

Steroid treatment

   

 Dexamethasone

13 (65.0)

29 (61.7)

42 (62.7)

 Prednisone

0

4 (8.5)

4 (6.0)

 Methylprednisolone

1 (5.0)

1 (2.1)

2 (3.0)

  1. BMI: Body mass index; CRP: C-reactive protein; ICU: Intensive care unit; LDH: Lactate Dehydrogenase; N: Number of patients; SpO2/FiO2: Peripheral oxygen saturation/Fraction of inspired oxygen. * N = 19 for placebo and N = 43 for eclitasertib 600 mg
  2. Note: Baseline is defined as the last available and evaluable value before the first administration of the Investigational Medicinal Product
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Respiratory Research

ISSN: 1465-993X

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