Viral Specific T-cells for Treatment of COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19

Conditions
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Viral Infection

Intervention / Treatment
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* Biological: Viral Specific T-cells (VSTs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have evidence of infection with SARS-CoV-2 Patients with symptomatic COVID-19 disease, as defined by at least one of the following Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection Requirement for supplemental oxygenation Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation Age >1 day Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent Have failed at least one FDA-approved treatment for COVID-19 disease 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: Uncontrolled bacterial or fungal infection Uncontrolled relapse of malignancy Unlikely to survive within 48 hours of VST infusion

Ages Eligible for Study
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Minimum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viral Specific T-cells (VSTs)<br> | Biological: Viral Specific T-cells (VSTs)<br>* VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful production of viral specific T-cells | Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria. | Within 30 days post culture initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of viral-specific T-cells | Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay | At 30 days after infusion |