Trial Outcomes & Findings for Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS (NCT NCT04615429)
NCT ID: NCT04615429
Last Updated: 2026-03-17
Results Overview
Change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7. If an arterial blood gas result cannot be obtained, the SaO2/FiO2 ratio could be substituted for the PaO2/FiO2 ratio
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
7 days
Results posted on
2026-03-17
Participant Flow
Participant milestones
| Measure |
Mesenchymal Stromal Cells
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS
Baseline characteristics by cohort
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
4 Participants
n=108 Participants
|
|
Age, Continuous
|
59.5 years
n=10 Participants
|
65.5 years
n=50 Participants
|
63.5 years
n=108 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
2 Participants
n=50 Participants
|
7 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
8 Participants
n=50 Participants
|
13 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=10 Participants
|
9 Participants
n=50 Participants
|
16 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=10 Participants
|
10 Participants
n=50 Participants
|
19 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=10 Participants
|
10 participants
n=50 Participants
|
20 participants
n=108 Participants
|
|
Weight
|
82.5 Kg
STANDARD_DEVIATION 16.0 • n=10 Participants
|
94.3 Kg
STANDARD_DEVIATION 18.9 • n=50 Participants
|
88.4 Kg
STANDARD_DEVIATION 18.1 • n=108 Participants
|
|
Height
|
164.2 cm
STANDARD_DEVIATION 11.3 • n=10 Participants
|
171.0 cm
STANDARD_DEVIATION 8.1 • n=50 Participants
|
167.8 cm
STANDARD_DEVIATION 10.1 • n=108 Participants
|
|
Body Mass Index
|
29.0 Kg/m2
STANDARD_DEVIATION 3.1 • n=10 Participants
|
32.0 Kg/m2
STANDARD_DEVIATION 4.5 • n=50 Participants
|
31.5 Kg/m2
STANDARD_DEVIATION 3.8 • n=108 Participants
|
|
Comorbidities
Diabetes mellitus
|
4 participants
n=10 Participants
|
2 participants
n=50 Participants
|
6 participants
n=108 Participants
|
|
Comorbidities
Obesity
|
3 participants
n=10 Participants
|
6 participants
n=50 Participants
|
9 participants
n=108 Participants
|
|
Comorbidities
Cardiovascular disorder (including HBP)
|
9 participants
n=10 Participants
|
6 participants
n=50 Participants
|
15 participants
n=108 Participants
|
|
Comorbidities
Chronic lung disease
|
1 participants
n=10 Participants
|
2 participants
n=50 Participants
|
3 participants
n=108 Participants
|
|
Concomitant treatments
Remdesivir
|
0 participants
n=10 Participants
|
1 participants
n=50 Participants
|
1 participants
n=108 Participants
|
|
Concomitant treatments
Glucocorticoid therapy
|
10 participants
n=10 Participants
|
10 participants
n=50 Participants
|
20 participants
n=108 Participants
|
|
Concomitant treatments
Tocilizumab
|
10 participants
n=10 Participants
|
9 participants
n=50 Participants
|
19 participants
n=108 Participants
|
|
Concomitant treatments
Low molecular weight heparin
|
10 participants
n=10 Participants
|
10 participants
n=50 Participants
|
20 participants
n=108 Participants
|
|
PaO2/FiO2 ratio at baseline
|
99.5 ratio of PAO2/FiO2
STANDARD_DEVIATION 42.1 • n=10 Participants
|
91.0 ratio of PAO2/FiO2
STANDARD_DEVIATION 37.6 • n=50 Participants
|
95.3 ratio of PAO2/FiO2
STANDARD_DEVIATION 39.1 • n=108 Participants
|
|
WHO Score (7 points)
4: Hospitalized, requiring supplemental oxygen by mask or nasal prongs
|
1 participants
n=10 Participants
|
1 participants
n=50 Participants
|
2 participants
n=108 Participants
|
|
WHO Score (7 points)
5: Hospitalized, on non-invasive ventilation or high flow devices
|
6 participants
n=10 Participants
|
5 participants
n=50 Participants
|
11 participants
n=108 Participants
|
|
WHO Score (7 points)
6: Hospitalized, on invasive mechanical ventilation
|
3 participants
n=10 Participants
|
4 participants
n=50 Participants
|
7 participants
n=108 Participants
|
|
Time from symptom onset to randomization
|
11.00 days
n=10 Participants
|
11.5 days
n=50 Participants
|
11.0 days
n=108 Participants
|
|
Lymphocytes
|
0.88 cells*10^3/microL
STANDARD_DEVIATION 0.59 • n=10 Participants
|
0.70 cells*10^3/microL
STANDARD_DEVIATION 0.55 • n=50 Participants
|
0.79 cells*10^3/microL
STANDARD_DEVIATION 0.56 • n=108 Participants
|
|
Neutrophil-lymphocyte ratio
|
18.12 Neutrophil-lymphocyte ratio
STANDARD_DEVIATION 22.46 • n=10 Participants
|
14.95 Neutrophil-lymphocyte ratio
STANDARD_DEVIATION 6.79 • n=50 Participants
|
16.54 Neutrophil-lymphocyte ratio
STANDARD_DEVIATION 16.23 • n=108 Participants
|
|
C-reactive protein
|
98.45 mg/L
STANDARD_DEVIATION 70.46 • n=10 Participants
|
95.64 mg/L
STANDARD_DEVIATION 111.54 • n=50 Participants
|
96.89 mg/L
STANDARD_DEVIATION 92.91 • n=108 Participants
|
|
IL-6
|
307.95 pg/mL
STANDARD_DEVIATION 380.18 • n=10 Participants
|
450.22 pg/mL
STANDARD_DEVIATION 555.46 • n=50 Participants
|
375.34 pg/mL
STANDARD_DEVIATION 463.38 • n=108 Participants
|
|
D-dimer
|
1480.00 ng/mL
STANDARD_DEVIATION 2444.40 • n=10 Participants
|
1360.00 ng/mL
STANDARD_DEVIATION 279.68 • n=50 Participants
|
1420.00 ng/mL
STANDARD_DEVIATION 1694.45 • n=108 Participants
|
|
LDH
|
406.33 U/L
STANDARD_DEVIATION 128.89 • n=10 Participants
|
356.20 U/L
STANDARD_DEVIATION 120.11 • n=50 Participants
|
379.95 U/L
STANDARD_DEVIATION 123.51 • n=108 Participants
|
PRIMARY outcome
Timeframe: 7 daysChange in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7. If an arterial blood gas result cannot be obtained, the SaO2/FiO2 ratio could be substituted for the PaO2/FiO2 ratio
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration
|
83.3 mmHg/mmHg
Standard Deviation 67.4
|
57.6 mmHg/mmHg
Standard Deviation 40.6
|
SECONDARY outcome
Timeframe: From baseline until day 7, and on day 28 after treatmentSecondary endpoint. Categories: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, on invasive mechanical ventilation or ECMO . 7. Death.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Improvement of ≥1 Category at World Health Organization 7 Point Scale
At day 28
|
8 participants
|
9 participants
|
|
Improvement of ≥1 Category at World Health Organization 7 Point Scale
At day 7
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Data was only available for 17 of the participants.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=9 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=8 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Time to Improvement of ≥1 Category at WHO 7-point Scale
|
10 days
Interval 7.0 to 18.0
|
13.5 days
Interval 12.0 to 16.0
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Patients That Had Oxygen Therapy Withdrawn by Day 28
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 7 participants in the MSC group and 5 participants in the control group discontinued oxygen therapy. Descriptive outcomes regarding the time to discontinue oxigen support were calculated only on the participants that were able to discontinue oxigen supplementation
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=7 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=5 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Time to Discontinuation of Oxygen Therapy (WHO ≤3)
|
14 days
Interval 10.0 to 18.0
|
23 days
Interval 20.0 to 25.0
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Proportion of Patients That Were Discharged at Day 28
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Duration of Hospitalization
|
17.5 days
Interval 11.0 to 28.0
|
28 days
Interval 26.0 to 28.0
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Proportion of Patients That Required ICU Admission
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only participants admitted to ICU were considered for this outcome
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=5 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=8 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Duration of ICU Admission
|
17 days
Interval 9.0 to 28.0
|
16 days
Interval 13.0 to 17.0
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Mortality at Day 28
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=10 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Mortality at 12 Months
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: MSC: Data available for 8 of 10 patients. Control Group: Data available for 9 of 10 patients.
New onset fibrosis at 12 months based on CT/X-ray imagine and pulmonary function tests.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=8 Participants
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=9 Participants
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
New Onset Fibrosis at 12 Months
|
4 Participants
|
1 Participants
|
Adverse Events
Mesenchymal Stromal Cells
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mesenchymal Stromal Cells
n=10 participants at risk
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 participants at risk
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • Number of events 1 • 1 Year
|
20.0%
2/10 • Number of events 2 • 1 Year
|
|
Infections and infestations
Bloodstream infection
|
10.0%
1/10 • Number of events 1 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Vascular disorders
Shock
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Infections and infestations
Complicated UTI
|
0.00%
0/10 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac infarction
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
Other adverse events
| Measure |
Mesenchymal Stromal Cells
n=10 participants at risk
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells
|
Control Group
n=10 participants at risk
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
Additional Information
Cristina Avendaño-Sola MD, PhD
Puerta de Hierro University Hospital
Phone: +34911916479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place