Clinical trial NCT04451291: Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
Official title: DSC-COVID-19: An Open-label Study on the Safety and Efficacy of Decidual Stromal Cells in Respiratory Failure Induced by COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Acute Respiratory Distress Syndrome
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2020-06-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of ventilator free days following infusion of decidual stromal cells
timeFrame: 28 days
Secondary outcomes:
measure: Mortality rate from COVID-19
timeFrame: 28 days
measure: Mortality rate from COVID-19
timeFrame: 60 days
measure: Mortality rate from COVID-19
timeFrame: 180 days
measure: All-cause morality rate
timeFrame: 28 days
measure: All-cause morality rate
timeFrame: 60 days
measure: All-cause morality rate
timeFrame: 180 days
measure: Average number of days in ICU
timeFrame: 180 days
measure: Average number of days of hospital admittance
timeFrame: 180 days
measure: Average days not requiring vasopressors
timeFrame: 180 days
measure: Overall survival rate
timeFrame: 180 days
measure: Average viral clearance
timeFrame: 180 days
measure: Average number of days of supplemental oxygenation
timeFrame: 180 days
measure: Average number of day without supplemental oxygen
timeFrame: 180 days
measure: Mean PaO2/FiO2 as compared to patient baseline
timeFrame: 180 days
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Brampton Civic Hospital
state: Ontario
city: Etobicoke
country: Canada
facility: Etobicoke General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: John Granton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: