Acute Respiratory Distress Syndrome, Covid19
Conditions
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.
Interventions
BIOLOGICALT regulatory cells
T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants that experience the occurrence of infusion associated adverse events (AEs) | within 6 hours of study 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Mortality following initial infusion | 28 days | — |
| 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). |
| 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. |
Countries
United States
Outcome results
None listed