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Table 2 Primary and secondary efficacy outcomes

From: Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

 

Baricitinib group (N = 139)

Placebo group (N = 136)

Adjusted Absolute difference

(95% CI)

Adjusted OR

(95% CI)

P-value*

Mortality

Number of deaths at day 61

21

21

   

Proportion (95% CI) at day 61

15.1 (9.6–22.2)

15.4 (9.8–22.6)

− 0.1 (− 8.3–8.0)

0.99 (0.50–1.95)

0.9733

Number of deaths at day 28+

14

18

   

Proportion (95% CI) at day 28+

10.1 (5.6–16.3)

13.2 (8.0–20.1)

− 2.9 (− 10.1–4.3)

0.75 (0.35–1.59)

0.4480

Disease progression

Number of progressions at day 28

25

27

   

Proportion (95% CI) at day 28

18.0 (12.0–25.4)

19.9 (13.5–27.6)

− 1.2 (− 10.0–7.4)

0.92 (0.49–1.72)

0.7943

 

Baricitinib group (N = 139)

Placebo group (N = 136)

Unadjusted sHR or OR (95% CI)

Adjusted sHR or OR

(95% CI)

p value*

Sustained recovery

Number of recoveries at day 91

107

106

   

Cumulative incidence at day 91% (95% CI)

78.8 (72.6–85.4)

79.1 (72.9–85.8)

0.99 (0.76–1.28)

0.98 (0.75–1.28)

0.8604

Hospital discharge

Number of discharges at day 91

111

107

   

Cumulative incidence at day 91% (95% CI)

83.8 (77.7–90.3)

79.8 (73.1–87.1)

1.14 (0.88–1.47)

1.14 (0.87–1.48)

0.3490

Ordinal scale at day 15 – n (%)

  

0.94 (0.60–1.48)

0.95 (0.60–1.50)

0.8296

Mild (WHO score 1–3)

81 (58.3)

74 (54.4)

   

Moderate (WHO score 4–5)

15 (10.8)

18 (13.2)

   

Severe (WHO score 6)

10 (7.2)

8 (5.9)

   

Critical (WHO score 7–9)

24 (17.2)

26 (19.1)

   

Death (WHO score 10)

25 (6.5)

10 (7.4)

   

Ordinal scale at day 29 – n (%)

  

1.13 (0.69–1.84)

1.14 (0.70–1.87)

0.5986

Mild (WHO score 1–3)

96 (69.0)

89 (65.4)

   

Moderate (WHO score 4–5)

97 (7.9)

14 (10.3)

   

Severe (WHO score 6)

3 (2.2)

4 (3.0)

   

Critical (WHO score 7–9)

4 (10.8)

11 (8.1)

   

Death (WHO score 10)

14 (10.1)

18 (13.2)

   
  1. *p values were obtained using logistic regression or Fine & Gray method with adjustment on stratification factor or proportional odds model
  2. + Post hoc analysis for comparison with other trials