This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced age, or other underlying health conditions. The outcomes of patients receiving the T cells (Arm A) will be compared to patients treated with standard of care (Arm B).
T cells that recognize COVID-19 peptides will be manufactured at Thomas Jefferson University and are frozen and ready for use. The T cells have to have an immune protein called HLA in common with a patient to work. If a patient enrolled on the COVID-19 study has this HLA, they will receive a dose of the COVID-19 T cells. Groups of 3-6 patients will be treated at each testing dose level. There are four dose levels of T cells: 1 x 105/kg, 3 x 105/kg, 1 x 106/kg, and 3 x 106/kg. Patients will receive the T cells intravenously in the hospital and be monitored there for 4 days before being discharged. Before discharge, patients will be taught to take and record their temperature, blood pressure, and oxygen levels (using a finger monitor) at home. After discharge, study staff will continue to monitor patient symptoms and recordings with video visits or phone calls daily until the monitoring period of 14 days is over. Patients will also be asked to give blood samples 7, 14, 28, days and 2, 3, and 6 months after the T cells are given. Patients who meet study criteria and wish to participate but do not have the HLA protein in common with the T cells, will be monitored by study personnel in their own homes for the full 14 day period. These patients will also be taught to take and record their temperature, blood pressure, and oxygen level. Study personnel will contact them daily by video or voice calls and check on the results of their readings and their symptoms. These patients may be treated with any standard or experimental COVID-19 therapy. How patients handle their COVID-19 infection will be compared between the group of people receiving the T cells and the group of people who do not receive the T cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Given IV. Cytotoxic T Lymphocytes collected from healthy volunteer donors who have recovered from COVID-19. The T cells are collected, manufactured to be COVID-specific, and stored frozen at Thomas Jefferson University.
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Safety of COVID-19-specific CTLs: Infusion Reactions
Safety will be measured by the absence of: Grade ≥ 3 acute infusion reactions
Time frame: Within 48 Hours of CTL Infusion
Safety of COVID-19-specific CTLs: Grade 4 AEs
Safety will be measured by the absence of: Any grade 4 or higher adverse event thought to be related to the CTL therapy and outside the spectrum of identified COVID related events.
Time frame: Within 14 days of CTL infusion
Safety of COVID-19-specific CTLs: GVHD
Safety will be measured by the absence of: Any manifestation of acute GVHD (for acute grades 2-4 GVHD-Glucksberg criteria) 53 resistant to 2 mg/kg of solumedrol or equivalent
Time frame: Within 14 days of CTL infusion
Safety of COVID-19-specific CTLs: Marrow Aplasia
Safety will be measured by the absence of: Marrow aplasia due to 3rd party engraftment
Time frame: Within 14 days of CTL infusion
Safety of COVID-19-specific CTLs: Neurotoxicty
Safety will be measured by the absence of: Grade ≥ 2+ Neurotoxicity as measured by the ASTCT/ICANS consensus grading system
Time frame: Within 14 days of CTL infusion
Safety of COVID-19-specific CTLs: CRS
Safety will be measured by the absence of: Grade ≥ 2+ CRS as measured by the ASTCT Consensus Grading Criteria for CRS
Time frame: Within 14 days of CTL infusion
Measurement of COVID-19 viral load
Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 14 Days
Studies to detect the persistence of the COVID-19-specific T cells after COVID-19 T cell infusion
Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
Time frame: Up to 6 months
Studies to examine the development of endogenous COVID-19 specific T cells
Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
Time frame: Up to 6 months
Studies to examine the development of anti-COVID-19 antibodies
Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
Time frame: Up to 6 months
Review of medical history including the need for supplemental oxygen, the ability to return to work, performance status, grade of dyspnea, grade of fatigue, survival, the need for blood pressure support
Patients will have their medical course followed by the study team
Time frame: Up to 6 months