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

Stanford University

Status and phase: Withdrawn; Phase 1

Conditions: Acute Respiratory Distress Syndrome; Covid19

Treatments: Biological: T regulatory cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04737161

56248

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

T regulatory cell infusion

Experimental group

Description:

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

Treatment:

Biological: T regulatory cells