Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

Study Overview
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Brief Summary
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This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.

Detailed Description
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This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4. Acceptable standard of care treatments for COVID-19 include all approved or emergency use authorized treatments for COVID-19, even if used off-label.

Official Title
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Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells

Conditions
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Covid19

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300 Requires oxygen supplementation at Screening Willing to follow contraception guidelines Exclusion Criteria: Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving A previous stem cell infusion unrelated to this trial Certain medical conditions that pose a safety risk to the subject Pregnant or breast feeding or planning to during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection History of splenectomy, lung transplant, or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days Has an existing Do Not Intubate order Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing

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>Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 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>|
| Placebo Comparator: Placebo<br>Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 | Drug: Placebo<br>* Excipient solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate at Day 28 | All-cause mortality rate at Day 28 | Baseline through Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate at Day 60 and Day 90 | All-cause mortality rate at Day 60 and Day 90 | Baseline through Day 60 and Day 90 | 
| Number of ventilator-free days through Day 28 | Number of ventilator-free days through Day 28 | Baseline through Day 28 | 
| Number of ICU days through Day 28 | Number of ICU days through Day 28 | Baseline through Day 28 | 
| Change in clinical status | Change in clinical status as assessed using the 11-point WHO Clinical Progression Scale (0-10, where lower score means a better outcome) | Baseline to Day 28 | 
| Change in oxygenation | Change in oxygenation as assessed using PaO2:FiO2 ratio | Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19