Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure

Study Overview
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Brief Summary
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This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.

Detailed Description
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COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or death due to respiratory failure. Decidual Stromal Cells (DSC) may be useful in the treatment of acute respiratory distress syndrome (ARDS) by reducing lung inflammation and then time that patients require help with breathing (mechanical ventilation).

Official Title
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DSC-COVID-19: An Open-label Study on the Safety and Efficacy of Decidual Stromal Cells in Respiratory Failure Induced by COVID-19

Conditions
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COVID-19, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Biological: Decidual Stromal Cells (DSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent for participation in the study, either by the participant themselves or by the legally acceptable representative (LAR) Virological diagnosis of SARS-CoV-2 infection (PCR) Acute respiratory distress syndrome (ARDS) not due to cardiac causes Receiving mechanical ventilation Exclusion Criteria: Severe comorbidity with life expectancy <3 months according to investigators assessment Currently receiving extracorporeal membrane oxygenation (ECMO) Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia Patients with diagnosed significant pulmonary embolism or deep vein thrombosis in the previous 3 months Patients who have been intubated for more than 48 hours Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins Acute co-morbidity within 7 days before inclusion such as stroke History of severe chronic history of heart disease, recent myocardial infarction or unstable angina, lung disease (requiring home oxygen), pulmonary hypertension, or liver comorbidities Malignancy that requires treatment in the previous two years (excluding non-melanoma skin malignancies treated by excision, or cryotherapy) History of immunosuppression (immunomodulators or anti-rejection drugs in past year, or active disease, autoimmune disease on treatment, transplant recipients) or anaphylaxis Refusal of blood products Severe co-morbidity/co-morbidities which in the opinion of the investigators would compromise safety assessments Pregnant or breast-feeding Actively participating on another trial of an investigational agent for ARDS Unacceptable laboratory blood tests for alanine aminotransferase (ALT)/aspartate aminotransferase (AST), neutrophils, or platelets

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decidual Stromal Cells (DSC)<br>Participants will receive one dose of DSC at 1x10^6/kg. A second dose may be given sometime between Day 5 and Day 8 if the participant's condition improves. | Biological: Decidual Stromal Cells (DSC)<br>* DSCs are involved in the immune system during pregnancy. The DSCs used in this study will come from laboratory grown allogeneic human decidual stromal cells obtained from donated placentas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilator free days following infusion of decidual stromal cells |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate from COVID-19 |  | 28 days | 
| Mortality rate from COVID-19 |  | 60 days | 
| Mortality rate from COVID-19 |  | 180 days | 
| All-cause morality rate |  | 28 days | 
| All-cause morality rate |  | 60 days | 
| All-cause morality rate |  | 180 days | 
| Average number of days in ICU |  | 180 days | 
| Average number of days of hospital admittance |  | 180 days | 
| Average days not requiring vasopressors |  | 180 days | 
| Overall survival rate |  | 180 days | 
| Average viral clearance |  | 180 days | 
| Average number of days of supplemental oxygenation |  | 180 days | 
| Average number of day without supplemental oxygen |  | 180 days | 
| Mean PaO2/FiO2 as compared to patient baseline |  | 180 days |