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

Phase 1

Withdrawn

• Conditions: Covid19; Acute Respiratory Distress Syndrome
• Interventions: Biological: T regulatory cells

• Registration Number: NCT04737161
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Study Start: 2021-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T regulatory cell infusion	T regulatory cells	Infusion will be administered to the patient within 72 hours of collection from donor.

Primary Outcome Measures

Name	Time	Method
The number of participants that experience the occurrence of infusion associated adverse events (AEs)	within 6 hours of study infusion
The number of patients who receive the target dose for one or more intravenous infusions	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.
The number of patients that experience treatment emergent AEs	6 to 24 hours after infusion treatment	Treatment related adverse events or serious adverse events

Secondary Outcome Measures

Name	Time	Method
World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement	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).
Mortality following initial infusion	28 days
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)	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.
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)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States