Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19, The BAT IT Study

Inclusion Criteria

• SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) from a nasopharyngeal swab or other accepted specimen type. (If testing was performed >= 5 days before enrollment, this must be repeated and accept only if positive again). Date of COVID test must be =< 5 days prior to infusion
• Currently hospitalized adult patient (>= 18 years of age) requiring medical care for COVID19
• Peripheral oxygen saturation (SpO2) >= 92% on room air
• Hemoglobin (Hgb) >= 7.0 gm/dl
• Negative pregnancy test (if applicable)
• Patient or parent/guardian capable of providing informed consent (may be obtained electronically)
• Evidence of pulmonary infiltrates on chest imaging * Any chest imaging findings which would be consistent with COVID19 would qualify (Eg: ground glass opacities, multifocal infiltrates etc.)
• High risk of requiring mechanical ventilation as defined by at least two of the following: * Age >= 60 years of age * Hypertension * Chronic cardiovascular disease other than hypertension (HTN) (eg: Coronary artery disease, congestive heart failure or cardiomyopathies) * Diabetes mellitus * Obesity (body mass index [BMI] > 30) * Active cancer diagnosis or ongoing (within 3 months) cytotoxic chemo/ radio-therapy for a cancer * Post-hematopoietic stem cell or solid organ transplantation status * Immunodeficiency states as determined by the treating physician (eg: receiving immunosuppressive therapy like rituximab or congenital immunodeficiency syndromes, prior treatment with chemotherapy > 3 months ago but per investigators discretion could have lingering effects on the immune system, eg: chemotherapy regimens for lymphomas, acute lymphoblastic leukemia [ALL] or acute myeloid leukemia [AML] etc.)

Exclusion Criteria

• Received anti-thymocyte globulin (ATG), Campath or other T cell immunosuppressive monoclonal antibodies in the 28 days prior to screening for enrollment
• Requiring mechanical ventilation at time of T cell infusion
• Alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal
• If previously undergone an allogeneic hematopoietic Cell Transplantation (HSCT) and have evidence of active acute graft versus host disease (GVHD) > grade 2
• Uncontrolled relapse of malignancy
• Requiring vasopressors
• Evidence of prior human immunodeficiency virus (HIV) infection
• Known history of autoimmune disease except prior thyroiditis
• Is not suitable at the discretion of the treating physician
• Patients on > 6 mg/day of dexamethasone (IV) per day or equivalent
• > grade 1 cytokine release syndrome (CRS) per American Society for Transplantation and Cellular Therapy (ASTCT) criteria
• Patients should not be enrolled on any other interventional clinical trials for COVID19. Patients may receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other Food and Drug Administration (FDA)-Emergency Use Authorization (EUA) approved products and thromboprophylaxis)