A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

Study Overview
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Brief Summary
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This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.

Detailed Description
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This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.

Official Title
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A Phase II, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients With Moderate to Severe ARDS Due to COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Biological: hMSC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition: Bilateral chest radiograph infiltrates. PaO2:FiO2 ratio of less than 200. Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema) Absence of moribund state that would indicate imminent demise and poor chance of survival. Exclusion Criteria: Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded. Breastfeeding mothers Patients on ECMO Receiving concurrent treatment with an investigational agent in a clinical trial. Exception: Use of COVID-19 convalescent plasma is permitted. More than 72hrs on mechanical ventilation before randomization Receiving concurrent investigational vaccine

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: hMSCs<br>hMSCs will be given via IV administration. | Biological: hMSC<br>* IV administration<br>* Other names: allogeneic mesenchymal bone marrow cells;|
| Placebo Comparator: Lactated Ringer's Solution<br>Lactated Ringer's Solution will be given via IV administration. | Biological: hMSC<br>* IV administration<br>* Other names: allogeneic mesenchymal bone marrow cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Number of patients alive at day 14 post treatment | 14 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 | Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared. | 9 months |