Viral Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALViral Specific T-cells (VSTs)
VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.
Sponsors
Hoxworth Blood Center
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful production of viral specific T-cells | Within 30 days post culture initiation | Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of viral-specific T-cells | At 30 days after infusion | Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay |
Countries
United States
Outcome results
None listed