Viral Specific T-cells for Treatment of COVID-19

Phase 2

Withdrawn

• Conditions: Viral Infection
• Interventions: Biological: Viral Specific T-cells (VSTs)

• Registration Number: NCT04406064
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Status Verified: 2021-01
• Study Start: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viral Specific T-cells (VSTs)	Viral Specific T-cells (VSTs)	-

Primary Outcome Measures

Name	Time	Method
Successful production of viral specific T-cells	Within 30 days post culture initiation	Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.

Secondary Outcome Measures

Name	Time	Method
Presence of viral-specific T-cells	At 30 days after infusion	Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States