The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA). COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.
Biological: Viral Specific T-cells (VSTs)
VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.
Inclusion Criteria:
1. Patients who have evidence of infection with SARS-CoV-2
2. Patients with symptomatic COVID-19 disease, as defined by at least one of the
following
1. Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19
infection
2. Requirement for supplemental oxygenation
3. Need for additional respiratory support, including, but not limited to High flow
02, CPAP, BiPAP, Mechanical ventilation
3. Age >1 day
4. Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other
steroid equivalent
5. Have failed at least one FDA-approved treatment for COVID-19 disease
6. Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or
sub-investigator either in person or by phone)
Exclusion Criteria:
1. Uncontrolled bacterial or fungal infection
2. Uncontrolled relapse of malignancy
3. Unlikely to survive within 48 hours of VST infusion
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Adam Nelson, MBBS, FRACP, Principal Investigator
Children's Hospital Medical Center, Cincinnati