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Replaced by a different protocol.
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This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.
This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.
COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-MSC 1 vial | Experimental | Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4. |
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| COVI-MSC 2 vials | Experimental | Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-MSC | Biological | COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-Minute Walk Distance (6MWD) at Day 60 | Change in 6MWD at Day 60 | Baseline to Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6MWD at Day 30 | Change in 6MWD at Day 30 | Baseline to Day 30 |
| Change in Pulmonary Function Tests (PFTs) | Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics, Inc. | Study Director |
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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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| Baseline to Day 30 and Day 60 |
| Change in oxygenation | Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio | Baseline to Day 30 and Day 60 |
| Change in biomarker levels | Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor | Baseline through Day 30 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |