Table 2 Primary and secondary outcomes in the mITT population

From: Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial

 

UC-MSC group (n = 65)

Placebo group (n = 35)

Difference

Change in the total lesion proportion (%) of the whole lung volume from baseline to day 28

−19.40 (−53.40, −2.62)

−7.30 (−46.59, 19.12)

−13.31 (−29.14, 2.13)†

Change in solid component lesion proportion (%) of whole lung volume from baseline to day 28

−57.70 (−74.95, −36.56)

−44.45 (−62.24, −8.82)

−15.45 (−30.82, −0.39)†

Change in ground-glass lesion proportion (%) of whole lung volume from baseline to day 28

−14.95 (−51.55, 7.29)

−3.94 (−43.99, 32.55)

−9.84 (−30.51, 6.86)†

6-minute walking distance at day 28 (meters)*

420.00 (392.00, 465.00)

403.00 (352.00, 447.00)

27.00 (0.00, 57.00)†

VCmax(L) at day 28

2.57 (2.13, 3.04)

2.49 (2.05, 2.76)

0.16 (−0.10, 0.43)†

DLco (L) at day 28‖

5.12 (1.62)

5.06 (1.57)

0.07 (−0.69, 0.82)

Six-category scale at day 10

  

0.77 (0.33, 1.79)&

1-Not hospitalized;

11 (16.92%)

6 (17.14%)

 

2-Hospitalized, not requiring supplemental oxygen

8 (12.31%)

6 (17.14%)

 

3-Hospitalized, requiring supplemental oxygen

44 (67.69%)

23 (65.71%)

 

4-Hospitalized, on noninvasive ventilation or high flow oxygen devices

2 (3.08%)

0 (0.00%)

 

Duration of oxygen therapy (days)‡

22.00 (13.00, 32.00)

31.00 (16.00, 36.00)

−7.00 (−17.00, 3.00)†

Finger pulse oxygen in resting state (%) at day 28§

97.10 (1.31)

96.97 (1.29)

0.13 (−0.42, 0.68)

mMRC dyspnea score at day 28**

  

1.49 (0.68, 3.26)&

Grade 0 n (%)

29 (47.54%)

13 (37.14%)

 

Grade 1 n (%)

24 (39.34%)

16 (45.71%)

 

Grade 2 n (%)

5 (8.20%)

4 (11.43%)

 

Grade 3 n (%)

3 (4.92%)

1 (2.86%)

 

Grade 4 n (%)

0 (0.00%)

1 (2.86%)

 
  1. Data are median (interquartile range, IQR), mean (SD) or n (%)
  2. *In the 6-minute walk test, there were three cases who could not complete the test because of cardiopulmonary function problems. The data were calculated as 0 meters
  3. †Differences are expressed as Hodges–Lehmann estimator and 95% confidence interval (CI)
  4. VCmax (L) at day 28 were available for 53 patients in the UC-MSC group and 31 patients in the placebo group
  5. ‖DLco (L) at day 28 were available for 53 patients in the UC-MSC group and 27 patients in the placebo group
  6. &Calculated by the ordinal logistic regression model. OR = odds ratio
  7. ‡Duration of oxygen therapy (days) were available for 29 patients in the UC-MSCs group and 11 patients in the placebo group
  8. §Finger pulse oxygen in resting state (%) at day 28 were available for 61 patients in the UC-MSCs group and 35 patients in the placebo group
  9. **mMRC dyspnea scores were available for 61 patients in the UC-MSCs group and 35 patients in the placebo group
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