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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.
Stanford University
Stanford, California, United States
The number of participants that experience the occurrence of infusion associated adverse events (AEs)
Time frame: within 6 hours of study infusion
The number of patients that experience treatment emergent AEs
Treatment related adverse events or serious adverse events
Time frame: 6 to 24 hours after infusion treatment
The number of patients who receive the target dose for one or more intravenous infusions
Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.
Time frame: up to 14 days (approximately 1.5 hours average per infusion)
The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time
Time frame: up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion)
World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement
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).
Time frame: assessed at 28 days post-infusion
Change in Sequential Organ Failure Assessment (SOFA) Score over time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)
Mortality following initial infusion
Time frame: 28 days