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Sorrento Therapeutics filed for chapter 11 bankruptcy.
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This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" 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 | Experimental | Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) |
|
| Placebo | Placebo Comparator | Excipient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-MSC | Biological | 2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group. Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4 Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4 Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2 Group D: 2 MSC vials infused on D0, D2 and D4 |
| 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 |
| Relief of symptoms on Day 30 and Day 60 | Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit |
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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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|
| Placebo | Biological | 6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4. |
|
| Baseline to Day 30 and Day 60 |
| Change in Pulmonary Function | Change in pulmonary function at Days 30 and 60, as measured by the single-breath test | Baseline to Day 30 and Day 60 |
| Change in oxygenation | Change in oxygenation at Days 30 and 60, as measured by the 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 to Day 60 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |