Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure (NCT04451291) | Clinical Trial Compass
CompletedNot Applicable
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
Canada19 participantsStarted 2020-09-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
* S…
What they're measuring
1
Number of ventilator free days following infusion of decidual stromal cells