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To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | Excipient |
|
| Arm 2 | Experimental | CK0802: 1x10^8 cells |
|
| Arm 3 | Experimental | CK0802: 3x10^8 cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK0802 | Biological | Cryopreserved, off the shelf, cord blood derived T regulatory cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regimen related ≥ grade 3 toxicity within 48 hours of first infusion | Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT) | 48 hours |
| 28-day treatment success, defined as S28 | Alive and not intubated 28 days after the date of first infusion | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | Time to extubation | 28 days |
| Oxygenation improvement | Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Columbia University |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
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| Placebo | Drug | Expicient |
|
| 11 days |
| Ventilator free days | Ventilator free days measured at day 28 | 28 days |
| Organ failure free days | Organ failure free days measured at day 28 | 28 days |
| ICU free days | ICU free days measured at day 28 | 28 days |
| All-cause mortality | All-cause mortality at day 28 | 28 days |
| New York |
| New York |
| 10027 |
| United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Baylor College of Medicine, St Luke's Hospital | Houston | Texas | 77005 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |