Back to resultsViral Specific T-cells for Treatment of COVID-19
Primary Purpose
Viral Infection
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Viral Specific T-cells (VSTs)
Sponsored by
About this trial
This is an interventional treatment trial for Viral Infection
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Viral Specific T-cells (VSTs)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Presence of viral-specific T-cells
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Full Information
NCT ID
NCT04406064
First Posted
May 26, 2020
Last Updated
January 14, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Hoxworth Blood Center
1. Study Identification
Unique Protocol Identification Number
NCT04406064
Brief Title
Viral Specific T-cells for Treatment of COVID-19
Official Title
Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Hoxworth Blood Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viral Specific T-cells (VSTs)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Viral Specific T-cells (VSTs)
Intervention Description
VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.
Primary Outcome Measure Information:
Title
Successful production of viral specific T-cells
Description
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Time Frame
Within 30 days post culture initiation
Secondary Outcome Measure Information:
Title
Presence of viral-specific T-cells
Description
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Time Frame
At 30 days after infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Nelson, MBBS, FRACP
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Viral Specific T-cells for Treatment of COVID-19
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