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

Withdrawn before enrolling · Phase 1

Conditions studied: Acute Respiratory Distress Syndrome, Covid19

In brief

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.

Key facts

Study ID

NCT04737161

Run by

Stanford University

People needed

0

Starts

2021-03-01

Expected to finish

2022-09-01

Last updated by the study team

2021-04-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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