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The use of steroids to treat COVID prevents the use of VSTs for these patients. The Principal Investigator does not feel the study had an expectation of enrolling patients as the treatment options for COVID have evolved.
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| Name | Class |
|---|---|
| Hoxworth Blood Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viral Specific T-cells (VSTs) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viral Specific T-cells (VSTs) | Biological | VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection. |
|
| 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 |
| 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 |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Nelson, MBBS, FRACP | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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