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Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will receive standard care. | |
| MSC - low dose (2.5x10ˆ7) | Experimental | Patients will receive standard care plus cell therapy. |
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| MSC - intermediate dose (5x10ˆ7) | Experimental | Patients will receive standard care plus cell therapy. |
|
| MSC - high dose (10x10ˆ7) | Experimental | Patients will receive standard care plus cell therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stromal cell-based therapy | Other | Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Intrahospital mortality | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in the ICU and Hospital | 28 days | |
| Days without mechanical ventilation in 28 days | 28 days | |
| PaO2 / FiO2 ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno SF Souza, MD PHD | Contact | +557132816455 | bruno.souza@hsr.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Rafael | Recruiting | Salvador | Estado de Bahia | 41253-190 | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Day 1, Day 2 and Day 7 after cell infusion |
| Incidence of secondary infections | 28 days |
| Incidence of adverse events | 28 days |
| Quantification of inflammatory response markers | Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry | Day 1, Day 3 and Day 7 after cell infusion |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |