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Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737161
Recruitment Status : Withdrawn (Funding not secured)
First Posted : February 3, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Covid19 Biological: T regulatory cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: T regulatory cell infusion
Infusion will be administered to the patient within 72 hours of collection from donor.
Biological: T regulatory cells
T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.




Primary Outcome Measures :
  1. The number of participants that experience the occurrence of infusion associated adverse events (AEs) [ Time Frame: within 6 hours of study infusion ]
  2. The number of patients that experience treatment emergent AEs [ Time Frame: 6 to 24 hours after infusion treatment ]
    Treatment related adverse events or serious adverse events

  3. The number of patients who receive the target dose for one or more intravenous infusions [ Time Frame: up to 14 days (approximately 1.5 hours average per infusion) ]
    Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.


Secondary Outcome Measures :
  1. 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) ]
  2. World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement [ Time Frame: assessed at 28 days post-infusion ]
    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).

  3. Change in Sequential Organ Failure Assessment (SOFA) Score over time [ Time Frame: up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion) ]
    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.

  4. Mortality following initial infusion [ Time Frame: 28 days ]


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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:

  • 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

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): NCT04737161


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Joe L Hsu, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04737161    
Other Study ID Numbers: 56248
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury