Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20-5527 | Other Identifier | University Health Network |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decidual Stromal Cells (DSC) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decidual Stromal Cells (DSC) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ventilator free days following infusion of decidual stromal cells | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate from COVID-19 | 28 days | |
| Mortality rate from COVID-19 | 60 days | |
| Mortality rate from COVID-19 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Granton, M.D. | Toronto General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brampton Civic Hospital | Brampton | Ontario | L6R 3J7 | Canada | ||
| Etobicoke General Hospital |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Etobicoke |
| Ontario |
| M9V 1R8 |
| Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |