Viral Specific T-cells for Treatment of COVID-19

Viral Infection Clinical Trial

Official title:

Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04406064
• Other study ID #: 2020-0353
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2021
• Est. completion date: June 2025

Study information

• Verified date: January 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Viral Infection
• Virus Diseases

Intervention

Biological:
• Viral Specific T-cells (VSTs)
VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Hoxworth Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 30 days post culture initiation
Secondary	Presence of viral-specific T-cells	Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay	At 30 days after infusion