NCT04451291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

June 26, 2020

Last Update Submit

February 1, 2024

Conditions

COVID-19Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of ventilator free days following infusion of decidual stromal cells

    28 days

Secondary Outcomes (14)

  • Mortality rate from COVID-19

    28 days

  • Mortality rate from COVID-19

    60 days

  • Mortality rate from COVID-19

    180 days

  • All-cause morality rate

    28 days

  • All-cause morality rate

    60 days

  • +9 more secondary outcomes

Study Arms (1)

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.

Biological: Decidual Stromal Cells (DSC)

Interventions

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.

Decidual Stromal Cells (DSC)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

Etobicoke General Hospital

Etobicoke, Ontario, M9V 1R8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • John Granton, M.D.

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

June 30, 2020

Study Start

September 25, 2020

Primary Completion

November 7, 2023

Study Completion

November 7, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

CA(3)