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Table 2 Change from baseline to weeks 2 and 4 of parameters in mITT population (М ± SD or n (%))

From: Efficacy and safety of Treamid in the rehabilitation of patients after COVID-19 pneumonia: a phase 2, randomized, double-blind, placebo-controlled trial

Parameter

Change from baseline to week 2

p-valuea

Change from baseline to week 4

p-valuea

Treamid

Placebo

Treamid

Placebo

6MWD (m)

39.8 ± 54.2

38.0 ± 40.7

0.98 (u)

78.6 ± 75.2

71.8 ± 50.2

0.960 (u)

6MWD (%, predicted)a

10.6 ± 14.0

11.0 ± 13.5

0.822 (u)

21.3 ± 23.1

19.7 ± 16.5

0.720 (u)

Borg scale (score)

− 0.5 ± 0.9

− 0.4 ± 0.8

0.411 (u)

− 0.9 ± 0.7

− 0.4 ± 0.8

0.018 (u)

mMRC scale (score)

− 0.6 ± 0.5

− 0.6 ± 0.5

0.717 (u)

− 1.1 ± 0.5

− 1.1 ± 0.6

0.683 (u)

KBILD questionnaire (total score)

7.4 ± 5.2

5.7 ± 3.9

0.585 (u)

13.8 ± 7.1

11.7 ± 10.0

0.117 (u)

 Breathlessness and activities

9.7 ± 8.7

8.7 ± 8.1

0.638 (u)

17.4 ± 9.1

16.5 ± 13.4

0.383 (u)

 Chest symptoms

13.3 ± 11.7

10.7 ± 9.5

0.471 (u)

22.1 ± 16.7

18.3 ± 14.3

0.134 (u)

 Psychological symptoms

8.8 ± 7.3

6.0 ± 7.6

0.387 (u)

16.7 ± 9.7

13.1 ± 13.2

0.145 (u)

Pulmonary function

 FEV1 (l)

0.1 ± 0.2

0.1 ± 0.2

0.617 (u)

0.1 ± 0.3

0.1 ± 0.3

0.678 (u)

 FVC (l)

0.1 ± 0.3

0.2 ± 0.4

0.755 (u)

0.1 ± 0.3

0.1 ± 0.3

0.725 (u)

 FEV1/FVC, %

0.6 ± 6.8

− 1.5 ± 5.9

0.466 (u)

2.3 ± 13.8

− 0.9 ± 4.5

0.936 (u)

 TLC (l)

0.3 ± 0.5

0.1 ± 0.7

0.149 (u)

0.3 ± 0.4

0.3 ± 0.8

0.210 (u)

 FRC (l)

0.0 ± 0.4

0.0 ± 0.6

0.431 (u)

0.1 ± 0.5

0.0 ± 0.7

0.604 (u)

 DLCO (mmol/min/kPa)

2.0 ± 2.7

1.7 ± 2.8

0.451 (u)

2.0 ± 2.4

1.5 ± 2.4

0.493 (t)

Pulmonary function (%, predicted)a

 FEV1

3.7 ± 9.0

4.8 ± 10.4

0.731 (u)

6.1 ± 19.1

3.4 ± 8.7

1.000 (u)

 FVC

4.3 ± 9.6

7.0 ± 12.0

0.838 (u)

4.0 ± 9.8

4.4 ± 8.8

0.805 (u)

 TLC

5.1 ± 11.3

2.0 ± 11.8

0.171 (u)

6.6 ± 8.9

5.3 ± 12.8

0.255 (u)

 FRC

1.2 ± 12.0

− 2.4 ± 15.0

0.216 (u)

2.6 ± 16.4

0.6 ± 16.4

0.421 (u)

 DLCO

8.7 ± 11.9

10.7 ± 17.2

0.864 (u)

10.4 ± 11.6

9.9 ± 14.1

0.575 (u)

Lung damage, %

   

− 14.0 ± 12.0

− 14.3 ± 12.9

0.962 (u)

CT score

 Increase or no change

   

9 (31)

10 (33)

 

 Decrease

   

20 (69)

20 (67)

0.850 (c)

  1. Data are mean ± SD or n (%). For abbreviations see Table 1
  2. aData are given in relation to baseline level. Data in bold indicates significant p-value (< 0.05)
  3. aTest is put in brackets: c—Chi-squared test, t—Student’s t-test, u—Mann–Whitney test
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Journal of Translational Medicine

ISSN: 1479-5876

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