BR: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: COVI-MSC Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) |
Biological: COVI-MSC
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
|
| Placebo Comparator: Placebo Excipient |
Biological: Placebo
6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
|
Outcome Measures
Primary Outcome Measures
- Change in 6-Minute Walk Distance (6MWD) at Day 60 [Baseline to Day 60]
Change in 6MWD at Day 60
Secondary Outcome Measures
- Change in 6MWD at Day 30 [Baseline to Day 30]
Change in 6MWD at Day 30
- Relief of symptoms on Day 30 and Day 60 [Baseline to 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
- Change in Pulmonary Function [Baseline to Day 30 and Day 60]
Change in pulmonary function at Days 30 and 60, as measured by the single-breath test
- Change in oxygenation [Baseline to Day 30 and Day 60]
Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio
- Change in biomarker levels [Baseline to Day 60]
Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
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Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
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Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
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Willing to follow contraception guidelines
Exclusion Criteria:
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Clinically improving pulmonary status over the month prior to screening
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Undergone a previous stem cell infusion unrelated to this trial
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Pregnant or breast feeding or planning for either during the study
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Suspected uncontrolled active bacterial, fungal, viral, or other infection
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Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
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History of a splenectomy, lung transplant or lung lobectomy
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Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sorrento Therapeutics, Inc.
Investigators
- Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MSC-PLH-201BR