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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002193-27 | EudraCT Number |
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A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
All trial participants will receive SOC*.
Randomization will be 1:1 between:
Treatment arm: allogenic MSC.
Control arm: Placebo (solution with the same composition as the experimental treatment, without the MSC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stromal cells | Experimental | Approximately 1x10E6 MSC/kg |
|
| Control group | Placebo Comparator | Solution identical to experimental treatment, without the MSC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stromal cells | Biological | Administration of one single dose of allogenic Mesenchymal stromal cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of ≥1 Category at World Health Organization 7 Point Scale | Secondary endpoint. Categories:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael F Duarte, MD, PhD | Hematology Department. Hospital Universitario Puerta de Hierro | Study Chair |
| Cristina Avedano-Sola, MD, PhD | Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro | Study Chair |
| Juan J Rubio, MD, PhD | ICU. Hospital Universitario Puerta de Hierro | Principal Investigator |
| Rosa Malo, MD | Respiratory Medicine Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro-Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33407777 | Background | Payares-Herrera C, Martinez-Munoz ME, Vallhonrat IL, de Molina RM, Torres MP, Trisan A, de Diego IS, Alonso R, Zafra R, Donaire T, Sanchez R, Rubio JJ, Duarte Palomino RF, Sola CA. Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 6;22(1):9. doi: 10.1186/s13063-020-04964-1. | |
| 38409332 |
| Label | URL |
|---|---|
| PubMed link | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mesenchymal Stromal Cells | Approximately 1x10E6 MSC/kg Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells |
| FG001 | Control Group | Solution identical to experimental treatment, without the MSC Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mesenchymal Stromal Cells | Approximately 1x10E6 MSC/kg Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration | 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 | Posted | Mean | Standard Deviation | mmHg/mmHg | 7 days |
|
1 Year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesenchymal Stromal Cells | Approximately 1x10E6 MSC/kg Mesenchymal stromal cells: Administration of one single dose of allogenic Mesenchymal stromal cells |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | This AE of special interest (AESI) was considered non-related to study treatment, and the patient recovered after surgery and local radiotherapy of the tumor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Avendaño-Sola MD, PhD | Puerta de Hierro University Hospital | +34911916479 | cavendanosola@salud.madrid.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2020 | Oct 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D003333 | Coronaviridae Infections |
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| Placebo | Other | Administration of placebo (solution identical to experimental treatment, without the MSC) |
|
| From baseline until day 7, and on day 28 after treatment |
| Time to Improvement of ≥1 Category at WHO 7-point Scale | 28 days |
| Patients That Had Oxygen Therapy Withdrawn by Day 28 | 28 days |
| Time to Discontinuation of Oxygen Therapy (WHO ≤3) | 28 days |
| Proportion of Patients That Were Discharged at Day 28 | 28 days |
| Duration of Hospitalization | 28 days |
| Proportion of Patients That Required ICU Admission | 12 months |
| Duration of ICU Admission | 12 months |
| Mortality at Day 28 | 28 days |
| Mortality at 12 Months | 12 months |
| New Onset Fibrosis at 12 Months | New onset fibrosis at 12 months based on CT/X-ray imagine and pulmonary function tests. | 12 months |
| Derived |
| Martinez-Munoz ME, Payares-Herrera C, Lipperheide I, Malo de Molina R, Salcedo I, Alonso R, Martin-Donaire T, Sanchez R, Zafra R, Garcia-Berciano M, Trisan-Alonso A, Perez-Torres M, Ramos-Martinez A, Ussetti P, Rubio JJ, Avendano-Sola C, Duarte RF. Mesenchymal stromal cell therapy for COVID-19 acute respiratory distress syndrome: a double-blind randomised controlled trial. Bone Marrow Transplant. 2024 Jun;59(6):777-784. doi: 10.1038/s41409-024-02230-5. Epub 2024 Feb 26. |
Solution identical to experimental treatment, without the MSC
Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | Kg/m2 |
|
| Comorbidities | Number | participants |
|
| Concomitant treatments | Number | participants |
|
| PaO2/FiO2 ratio at baseline | Mean | Standard Deviation | ratio of PAO2/FiO2 |
|
| WHO Score (7 points) | Number | participants |
|
| Time from symptom onset to randomization | Median | Inter-Quartile Range | days |
|
| Lymphocytes | Mean | Standard Deviation | cells*10^3/microL |
|
| Neutrophil-lymphocyte ratio | Mean | Standard Deviation | Neutrophil-lymphocyte ratio |
|
| C-reactive protein | Mean | Standard Deviation | mg/L |
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| IL-6 | Mean | Standard Deviation | pg/mL |
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| D-dimer | Mean | Standard Deviation | ng/mL |
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| LDH | Mean | Standard Deviation | U/L |
|
|
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| Secondary | Improvement of ≥1 Category at World Health Organization 7 Point Scale | Secondary endpoint. Categories:
| Posted | Number | participants | From baseline until day 7, and on day 28 after treatment |
|
|
|
| Secondary | Time to Improvement of ≥1 Category at WHO 7-point Scale | Data was only available for 17 of the participants. | Posted | Median | Inter-Quartile Range | days | 28 days |
|
|
|
| Secondary | Patients That Had Oxygen Therapy Withdrawn by Day 28 | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Time to Discontinuation of Oxygen Therapy (WHO ≤3) | 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 | Posted | Median | Inter-Quartile Range | days | 28 days |
|
|
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| Secondary | Proportion of Patients That Were Discharged at Day 28 | Posted | Count of Participants | Participants | 28 days |
|
|
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| Secondary | Duration of Hospitalization | Posted | Median | Inter-Quartile Range | days | 28 days |
|
|
|
| Secondary | Proportion of Patients That Required ICU Admission | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Duration of ICU Admission | Only participants admitted to ICU were considered for this outcome | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| Secondary | Mortality at Day 28 | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Mortality at 12 Months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | New Onset Fibrosis at 12 Months | New onset fibrosis at 12 months based on CT/X-ray imagine and pulmonary function tests. | MSC: Data available for 8 of 10 patients. Control Group: Data available for 9 of 10 patients. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| 1 |
| 10 |
| EG001 | Control Group | Solution identical to experimental treatment, without the MSC Placebo: Administration of placebo (solution identical to experimental treatment, without the MSC) | 1 | 10 | 7 | 10 | 0 | 10 |
| Bloodstream infection | Infections and infestations | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Shock | Vascular disorders | Non-systematic Assessment | Death, not related to the study treatment. |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment | Cardiac arrest due to an endotracheal tube occlusion by secretions; patient recovered with no sequelae. |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Complicated UTI | Infections and infestations | Non-systematic Assessment |
|
| Cardiac infarction | Cardiac disorders | Non-systematic Assessment |
|
|
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| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |