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Table 1 Characteristics of the study population and outcomes by assigned I-SPY COVID trial arm

From: Novel subtypes of severe COVID-19 respiratory failure based on biological heterogeneity: a secondary analysis of a randomized controlled trial

 

Control arm

(N = 142)

Investigational arm

(N = 258)

P value*

Age (mean ± SD)

59.3 ± 14.4

60.1 ± 14.0

0.6

Male sex

93 (66%)

174 (67%)

0.78

BMI (median (IQR))

32 (28 to 39)

32 (28 to 36)

0.26

Race

  

0.38

Black or African American

38 (27%)

51 (20%)

 

White or Caucasian

73 (51%)

141 (55%)

 

Other

8 (6%)

21 (8%)

 

Unknown

23 (16%)

45 (17%)

 

Ethnicity

  

0.17

Hispanic/Latinx

42 (30%)

69 (27%)

 

Not Hispanic/Latinx

98 (69%)

176 (68%)

 

Unknown

2 (1%)

13 (5%)

 

Comorbidities

   

Cerebrovascular disease

8 (6%)

13 (5%)

0.98

Congestive heart failure

11 (8%)

14 (5%)

0.48

Diabetes

56 (39%)

87 (34%)

0.3

Chronic kidney disease

21 (15%)

25 (10%)

0.22

End stage kidney disease

1 (0.7%)

1 (0.4%)

1

Dialysis

0 (0%)

2 (0.8%)

0.76

Hypertension

84 (59%)

144 (56%)

0.59

Liver disease—mild

2 (1%)

3 (1%)

1

Liver disease—moderate to severe

1 (0.7%)

1 (0.4%)

1

Myocardial infarction

5 (3%)

6 (2%)

0.7

Peripheral vascular disease

7 (5%)

6 (2%)

0.27

Chronic Lung disease

30 (21%)

49 (19%)

0.7

Chronic rheumatologic disease

8 (6%)

13 (5%)

0.98

COVID-19 severity—enrollment†

  

0.58

WHO 5

117 (82%)

221 (86%)

 

WHO 6

12 (9%)

15 (6%)

 

WHO 7

13 (9%)

22 (9%)

 

Respiratory support, enrollment

  

0.84

≤ 15 LPM oxygen

14 (10%)

28 (11%)

 

> 15 LPM oxygen

90 (63%)

165 (64%)

 

Noninvasive mechanical ventilation

13 (9%)

27 (11%)

 

Invasive Mechanical ventilation

25 (18%)

37 (14%)

 

Dexamethasone ≥ 6 mg‡

136 (96%)

251 (97%)

0.60

Other COVID-19 treatments

   

Tocilizumab

23 (16%)

45 (17%)

0.86

Convalescent plasma

6 (4%)

14 (5%)

0.77

Inhaled nitric oxide

12 (8%)

24 (9%)

0.92

Epoprostenol

29 (20%)

49 (19%)

0.83

Neuromuscular blockade

41 (29%)

83 (32%)

0.57

Baricitinib

2 (1%)

6 (2%)

0.72

Investigational agents

   

Razuprotafib

–

10 (4%)

 

Apremilast

–

31 (12%)

 

Aviptadil

–

20 (8%)

 

Celecoxib/Famotidine

–

18 (7%)

 

Cenicriviroc

–

43 (17%)

 

Cyclosporine

–

9 (3%)

 

Cyproheptadine

–

6 (2%)

 

IC14

–

40 (16%)

 

Icatibant

–

38 (15%)

 

Narsoplimab

–

22 (9%)

 

Pulmozyme

–

21 (8%)

 

28-day mortality

30 (21%)

71 (28%)

0.2

60-day mortality

36 (25%)

82 (32%)

0.22

  1. Numbers are presented as n (%) unless otherwise stated
  2. BMI body mass index, LPM liters per minute
  3. *Determined via Welch’s t-test for normally distributed continuous variables, Wilcoxon rank-sum for non-normally distributed continuous variables, and Chi-squared test or Fisher’s exact test for categorical variables
  4. †Using the WHO ordinal scale for COVID-19 severity; 5: hospitalized, noninvasive mechanical ventilation or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation
  5. ‡Completed course of steroid therapy prior to trial enrollment or receiving dexamethasone at the time of trial enrollment
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