Viral Specific T-cells for Treatment of COVID-19

Withdrawn before enrolling · Phase 2

Conditions studied: Viral Infection

In brief

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.

Key facts

Study ID

NCT04406064

Run by

Children's Hospital Medical Center, Cincinnati

People needed

0

Starts

2021-01-01

Expected to finish

2025-06-01

Last updated by the study team

2021-01-19

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Uncontrolled bacterial or fungal infection
• Uncontrolled relapse of malignancy
• Unlikely to survive within 48 hours of VST infusion

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.