Status:
WITHDRAWN
Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
Lead Sponsor:
Stanford University
Conditions:
Acute Respiratory Distress Syndrome
Covid19
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 ind...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04737161
Start Date
March 1 2021
End Date
September 1 2022
Last Update
April 19 2021
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305