Viral Specific T-cells for Treatment of COVID-19
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|ClinicalTrials.gov Identifier: NCT04406064|
Recruitment Status : Withdrawn (The use of steroids to treat COVID prevents the use of VSTs for these patients.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.)
First Posted : May 28, 2020
Last Update Posted : January 19, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Viral Infection||Biological: Viral Specific T-cells (VSTs)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2025|
|Experimental: Viral Specific T-cells (VSTs)||
Biological: Viral Specific T-cells (VSTs)
VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.
- Successful production of viral specific T-cells [ Time Frame: 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.
- Presence of viral-specific T-cells [ Time Frame: At 30 days after infusion ]Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406064
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Adam Nelson, MBBS, FRACP||Children's Hospital Medical Center, Cincinnati|