NCT04451291CompletedNot Applicable
DSC-COVID-19: An Open-label Study on the Safety and Efficacy of Decidual Stromal Cells in Respiratory Failure Induced by COVID-19
University Health Network, Toronto6 sites in 1 country19 target enrollmentStarted: September 25, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 6
- Primary Endpoint
- Number of ventilator free days following infusion of decidual stromal cells
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of ventilator free days following infusion of decidual stromal cells
Time Frame: 28 days
Secondary Outcomes
- Overall survival rate(180 days)
- All-cause morality rate(180 days)
- Average days not requiring vasopressors(180 days)
- Average number of days in ICU(180 days)
- Mortality rate from COVID-19(180 days)
- Average number of days of hospital admittance(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)
Investigators
Study Sites (6)
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