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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451291
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome Biological: Decidual Stromal Cells (DSC) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 24, 2020
Estimated Primary Completion Date : February 24, 2021
Estimated Study Completion Date : February 24, 2021


Arm Intervention/treatment
Experimental: Decidual Stromal Cells (DSC)
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)
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.




Primary Outcome Measures :
  1. Number of ventilator free days following infusion of decidual stromal cells [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Mortality rate from COVID-19 [ Time Frame: 28 days ]
  2. Mortality rate from COVID-19 [ Time Frame: 60 days ]
  3. Mortality rate from COVID-19 [ Time Frame: 180 days ]
  4. All-cause morality rate [ Time Frame: 28 days ]
  5. All-cause morality rate [ Time Frame: 60 days ]
  6. All-cause morality rate [ Time Frame: 180 days ]
  7. Average number of days in ICU [ Time Frame: 180 days ]
  8. Average number of days of hospital admittance [ Time Frame: 180 days ]
  9. Average days not requiring vasopressors [ Time Frame: 180 days ]
  10. Overall survival rate [ Time Frame: 180 days ]
  11. Average viral clearance [ Time Frame: 180 days ]
  12. Average number of days of supplemental oxygenation [ Time Frame: 180 days ]
  13. Average number of day without supplemental oxygen [ Time Frame: 180 days ]
  14. Mean PaO2/FiO2 as compared to patient baseline [ Time Frame: 180 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451291


Contacts
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Contact: John Granton, M.D. 416-340-4485 john.granton@uhn.ca
Contact: Jonas Mattsson, M.D. 416-946-4501 ext 3858 jonas.mattsson@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Contact: John Granton, M.D.    416-340-4485      
Principal Investigator: John Granton, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Oslo University Hospital
Investigators
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Principal Investigator: John Granton, M.D. Toronto General Hospital
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04451291    
Other Study ID Numbers: U-DEPLOY: DSC-COVID-19
20-5527 ( Other Identifier: University Health Network )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury