| |
UC-MSC
|
Placebo
|
Total
|
p value
|
|---|
|
Adverse events D0–D14
| | | | |
|
Subjects with AEs
|
18/21 (85.7%)
|
18/24 (75%)
|
36/45 (80%)
|
0.47
|
|
AEs reported
|
49/97 (50.5%)
|
48/97 (49.5%)
|
97 (100%)
|
0.29
|
|
Subjects with SAEs
|
6/21 (28.6%)
|
6/24 (25%)
|
12/45 (26.7%)
|
0.79
|
|
SAEs reported
|
10/49 (20.4%)
|
6/48 (12.5%)
|
16/97 (16.5%)
|
0.29
|
|
AEs by severity
| | | |
0.99
|
|
Mild
|
16/49 (32.7%)
|
15/48 (31.3%)
|
31/97 (32%)
| |
|
Moderate
|
24/49 (49%)
|
24/48 (50%)
|
48/97 (49.5)
| |
|
Severe
|
9/49 (18.4%)
|
9/48 (18.7%)
|
18/97 (18.6)
| |
|
AE gradea
| | | |
0.14
|
|
Grade 1
|
19/47(40.4%)
|
10/48 (20.8%)
|
29/95 (30.5%)
| |
|
Grade 2
|
15/47 (31.9%)
|
19/48 (39.6%)
|
34/95 (35.8%)
| |
|
Grade 3
|
9/47 (19.1%)
|
16/48 (33.3%)
|
25/95 (26.3%)
| |
|
Grade 4
|
4/47 (12.5%)
|
3/48 (6.3%)
|
7/95 (7.4%)
| |
|
AEs by treatment relatedness
| | | |
0.41
|
|
Possible
|
1/48 (2.1%)b
|
0 (0%)
|
1/95 (1.1%)
| |
|
Other treatment
|
4/48 (8.3%)
|
2/47 (4.3%)
|
6/95 (6.3%)
| |
|
Other disease
|
1/48 (2.1%)
|
1/47 (2.1%)
|
2/95 (2.1%)
| |
|
COVID-19 progression
|
28/48 (58.3%)
|
37/47 (78.7%)
|
65/95 (68.4%)
| |
|
Other causes
|
3/48 (6.3%)
|
2/47 (4.3%)
|
5/95 (5.3%)
| |
|
Undetermined
|
11/48 (22.9%)
|
5/47 (10.6%)
|
16/95 (16.8%)
| |
|
Adverse events after D14
| | | | |
|
Subjects with AEs
|
9/21 (38.1%)
|
9/24 (37.5%)
|
18/45 (40%)
|
0.71
|
|
AEs reported
|
19/42 (45.2%)
|
23/42 (54.8%)
|
42 (100%)
|
1.00
|
|
Subjects with SAEs
|
4/21 (19%)
|
4/24 (16.7%)
|
8/45 (17.8%)
|
1.00
|
|
SAEs reported
|
4/19 (21.1%)
|
4/23 (17.4%)
|
8/42 (19%)
|
1.00
|
|
AEs by severity
| | | |
0.19
|
|
Mild
|
7/19 (36.8%)
|
3/23 (13%)
|
10/42 (23.8%)
| |
|
Moderate
|
7/19 (36.8%)
|
12/23 (52.2%)
|
19/42 (45.2%)
| |
|
Severe
|
5/19 (26.3%)
|
8/23 (34.8%)
|
13/42 (31%)
| |
|
AE gradea
| | | |
0.18
|
|
Grade 1
|
7/18 (38.9%)
|
3/23 (13%)
|
10/41 (24.4%)
| |
|
Grade 2
|
7/18 (38.9%)
|
15/23 (65.2%)
|
22/41 (53.7%)
| |
|
Grade 3
|
1/18 (5.6%)
|
3/23 (1%)
|
4/41 (9.8%)
| |
|
Grade 4
|
3/18 (16.7%)
|
2/23 (8.7%)
|
5/41 (12.2%)
| |
|
AEs by treatment relatedness
| | | |
0.54
|
|
Possible
|
0 (0%)
|
0 (0%)
|
0 (0.0%)
| |
|
Other treatment
|
3/14 (21.4%)
|
4/20 (20%)
|
7/34 (20.6%)
| |
|
Other disease
|
1/14 (7.1%)
|
0 (0%)
|
1/34 (2.9%)
| |
|
COVID-19 progression
|
8/14 (57.1%)
|
11/20 (55%)
|
19/34 (55.9%)
| |
|
Other causes
|
2/14 (14.3%)
|
2/20 (10%)
|
4/34 (11.8%)
| |
|
Undetermined
|
0 (0%)
|
3/20 (15%)
|
3/34 (8.8%)
| |
- Values are expressed as number (%). AEs adverse events. SAEs severe adverse events. UC-MSC umbilical cord-derived mesenchymal stromal cells
- aGrade from the Common Terminology Criteria for Adverse Events classification
- bPossible non-serious treatment-related AE: diarrhoea
