Viral Specific T-cells for Treatment of COVID-19

Children's Hospital Medical Center, Cincinnati

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Viral Infection

Interventions

Viral Specific T-cells (VSTs)BIOLOGICAL

VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.

Eligibility

Sex: ALLMin age: 1 Day

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who have evidence of infection with SARS-CoV-2 2. Patients with symptomatic COVID-19 disease, as defined by at least one of the following 1. Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection 2. Requirement for supplemental oxygenation 3. Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation 3. Age \>1 day 4. Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent 5. Have failed at least one FDA-approved treatment for COVID-19 disease 6. 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: 1. Uncontrolled bacterial or fungal infection 2. Uncontrolled relapse of malignancy 3. Unlikely to survive within 48 hours of VST infusion

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Within 30 days post culture initiation

Secondary Outcomes

Presence of viral-specific T-cells

Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay

Time frame: At 30 days after infusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.