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 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 long haulers with pulmonary compromise.

Detailed Description
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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.

Official Title
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A Phase 2a 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


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 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-MSC 1 vial<br>Subjects will receive intravenous infusions of COVI-MSC (one vial,  18.5 million cells) on Day 0, Day 2, and Day 4. | Biological: COVI-MSC<br>* COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells<br>|
| Experimental: COVI-MSC 2 vials<br>Subjects will receive intravenous infusions of COVI-MSC (two vials,  37 million cells) on Day 0, Day 2, and Day 4. | Biological: COVI-MSC<br>* COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells<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 | 
| 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, long haul, post-acute covid