Status:
WITHDRAWN
Viral Specific T-cells for Treatment of COVID-19
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Hoxworth Blood Center
Conditions:
Viral Infection
Eligibility:
All Genders
1+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy
- Unlikely to survive within 48 hours of VST infusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04406064
Start Date
January 1 2021
End Date
June 1 2025
Last Update
January 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229