Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise

Conditions
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Covid19

Intervention / Treatment
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* Biological: COVI-MSC
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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 Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test) 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 Willing to follow contraception guidelines Exclusion Criteria: Clinically improving pulmonary status over the month prior to screening Undergone a previous stem cell infusion unrelated to this trial Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-MSC<br>Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) | Biological: COVI-MSC<br>* 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<br>|
| Placebo Comparator: Placebo<br>Excipient | Biological: Placebo<br>* 6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-Minute Walk Distance (6MWD) at Day 60 | Change in 6MWD at Day 60 | Baseline to Day 60 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, long haul, post-acute covid