Viral Specific T-cells for Treatment of COVID-19

NCT ID: NCT04406064

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2025-06-30

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.

Conditions

Viral Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Viral Specific T-cells (VSTs)

Group Type: EXPERIMENTAL

Viral Specific T-cells (VSTs)

Intervention Type: BIOLOGICAL

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

Interventions

Viral Specific T-cells (VSTs)

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoxworth Blood Center

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Nelson, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2020-0353

Identifier Type: -

Identifier Source: org_study_id