Back to resultsSafety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
Primary Purpose
Acute Respiratory Distress Syndrome, Covid19
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
T regulatory cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age 18 years to 75 years
- All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
- Provision of signed written informed consent from the patient or patients legally authorized representative
- Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
- Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
- COVID positive by PCR testing
Exclusion Criteria:
- Concurrent illness that shortens life expectancy to less than 6 months
- Inability to obtain adequate study follow-up
- Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T regulatory cell infusion
Arm Description
Infusion will be administered to the patient within 72 hours of collection from donor.
Outcomes
Primary Outcome Measures
The number of participants that experience the occurrence of infusion associated adverse events (AEs)
The number of patients that experience treatment emergent AEs
Treatment related adverse events or serious adverse events
The number of patients who receive the target dose for one or more intravenous infusions
Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.
Secondary Outcome Measures
The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time
World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement
The scale specifies a point value for each of the following parameters including: death (8 points), hospitalized on invasive mechanical ventilation and additional organ support including extracorporeal membrane oxygenation (ECMO) (7 points), hospitalized on invasive mechanical ventilation (6 points), hospitalized on non-invasive ventilation or high flow nasal cannula (HFNC) (5 points), hospitalized on supplemental oxygen (4 points), hospitalized not on supplemental oxygen (3 points), not hospitalized with limitation in activity (continued symptoms) (2 points) and not hospitalized without limitation in activity (no symptoms) (1 point) and no clinical or virological evidence of infection (0 points).
Change in Sequential Organ Failure Assessment (SOFA) Score over time
The SOFA score is designed to predict mortality based on the degree of dysfunction of six organ systems (neurologic, respiratory, cardiovascular, hepatic, coagulation and renal). Score range: 0-24 (summed from each of the 6 organ systems individually graded on a 0 to 4 scale); higher numbers represent a greater degree of organ dysfunction for the subscales and overall scale.
Mortality following initial infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04737161
Brief Title
Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
Official Title
A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not secured
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.
Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T regulatory cell infusion
Arm Type
Experimental
Arm Description
Infusion will be administered to the patient within 72 hours of collection from donor.
Intervention Type
Biological
Intervention Name(s)
T regulatory cells
Intervention Description
T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.
Primary Outcome Measure Information:
Title
The number of participants that experience the occurrence of infusion associated adverse events (AEs)
Time Frame
within 6 hours of study infusion
Title
The number of patients that experience treatment emergent AEs
Description
Treatment related adverse events or serious adverse events
Time Frame
6 to 24 hours after infusion treatment
Title
The number of patients who receive the target dose for one or more intravenous infusions
Description
Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.
Time Frame
up to 14 days (approximately 1.5 hours average per infusion)
Secondary Outcome Measure Information:
Title
The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time
Time Frame
up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion)
Title
World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement
Description
The scale specifies a point value for each of the following parameters including: death (8 points), hospitalized on invasive mechanical ventilation and additional organ support including extracorporeal membrane oxygenation (ECMO) (7 points), hospitalized on invasive mechanical ventilation (6 points), hospitalized on non-invasive ventilation or high flow nasal cannula (HFNC) (5 points), hospitalized on supplemental oxygen (4 points), hospitalized not on supplemental oxygen (3 points), not hospitalized with limitation in activity (continued symptoms) (2 points) and not hospitalized without limitation in activity (no symptoms) (1 point) and no clinical or virological evidence of infection (0 points).
Time Frame
assessed at 28 days post-infusion
Title
Change in Sequential Organ Failure Assessment (SOFA) Score over time
Description
The SOFA score is designed to predict mortality based on the degree of dysfunction of six organ systems (neurologic, respiratory, cardiovascular, hepatic, coagulation and renal). Score range: 0-24 (summed from each of the 6 organ systems individually graded on a 0 to 4 scale); higher numbers represent a greater degree of organ dysfunction for the subscales and overall scale.
Time Frame
up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)
Title
Mortality following initial infusion
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years to 75 years
All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
Provision of signed written informed consent from the patient or patients legally authorized representative
Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
COVID positive by PCR testing
Exclusion Criteria:
Concurrent illness that shortens life expectancy to less than 6 months
Inability to obtain adequate study follow-up
Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe L Hsu, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
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