Viral Specific T-cells for Treatment of COVID-19

Cincinnati Children's Hospital Medical Center

Status and phase: Withdrawn; Phase 2

Conditions: Viral Infection

Treatments: Biological: Viral Specific T-cells (VSTs)

Study type: Interventional

Funder types: Other

Identifiers

NCT04406064

2020-0353 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Viral Specific T-cells (VSTs)

Experimental group

Treatment:

Biological: Viral Specific T-cells (VSTs)