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This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.
Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T regulatory cell infusion | Experimental | Infusion will be administered to the patient within 72 hours of collection from donor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T regulatory cells | Biological | T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants that experience the occurrence of infusion associated adverse events (AEs) | within 6 hours of study infusion | |
| The number of patients that experience treatment emergent AEs | Treatment related adverse events or serious adverse events | 6 to 24 hours after infusion treatment |
| The number of patients who receive the target dose for one or more intravenous infusions | Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion. | up to 14 days (approximately 1.5 hours average per infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time | up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion) | |
| World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe L Hsu, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
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The scale specifies a point value for each of the following parameters including: death (8 points), hospitalized on invasive mechanical ventilation and additional organ support including extracorporeal membrane oxygenation (ECMO) (7 points), hospitalized on invasive mechanical ventilation (6 points), hospitalized on non-invasive ventilation or high flow nasal cannula (HFNC) (5 points), hospitalized on supplemental oxygen (4 points), hospitalized not on supplemental oxygen (3 points), not hospitalized with limitation in activity (continued symptoms) (2 points) and not hospitalized without limitation in activity (no symptoms) (1 point) and no clinical or virological evidence of infection (0 points).
| assessed at 28 days post-infusion |
| Change in Sequential Organ Failure Assessment (SOFA) Score over time | The SOFA score is designed to predict mortality based on the degree of dysfunction of six organ systems (neurologic, respiratory, cardiovascular, hepatic, coagulation and renal). Score range: 0-24 (summed from each of the 6 organ systems individually graded on a 0 to 4 scale); higher numbers represent a greater degree of organ dysfunction for the subscales and overall scale. | up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion) |
| Mortality following initial infusion | 28 days |
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |