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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04737161
• Other study ID #: 56248
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2021
• Est. completion date: September 2022

Study information

• Verified date: April 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Covid19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants that experience the occurrence of infusion associated adverse events (AEs)		within 6 hours of study infusion
Primary	The number of patients that experience treatment emergent AEs	Treatment related adverse events or serious adverse events	6 to 24 hours after infusion treatment
Primary	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	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)
Secondary	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).	assessed at 28 days post-infusion
Secondary	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.	up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)
Secondary	Mortality following initial infusion		28 days