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

NCT04737161 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 56248
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Covid19

Outcome Measures

Primary Outcomes (3)

• The number of participants that experience the occurrence of infusion associated adverse events (AEs)

  within 6 hours of study infusion

• The number of patients that experience treatment emergent AEs

  Treatment related adverse events or serious adverse events

  6 to 24 hours after infusion treatment

• 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.

  up to 14 days (approximately 1.5 hours average per infusion)

Secondary Outcomes (4)

• The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time

  up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion)

• World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement

  assessed at 28 days post-infusion

• Change in Sequential Organ Failure Assessment (SOFA) Score over time

  up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)

• Mortality following initial infusion

  28 days

Study Arms (1)

T regulatory cell infusion

EXPERIMENTAL

Infusion will be administered to the patient within 72 hours of collection from donor.

Biological: T regulatory cells

Interventions

T regulatory cells BIOLOGICAL

T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.

T regulatory cell infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Joe L Hsu, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 3, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)