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SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Sponsor: New York Medical College
Summary
The 2019 Severe Acute Respiratory Syndrome (SARS) is a global pandemic secondary to a novel coronavirus - SARS-CoV-2. The reported case-fatality ratio for SARS-CoV-2 in the United States is 1.8% with a current death toll of \>300,000 and climbing.4 There is no accepted standard of care or FDA approved therapies for treatment of COVID-19. Virus specific cytotoxic T lymphocytes (CTLs) have become an important part of the treatment landscape for viral reactivation post hematopoietic and solid organ transplantation. Donor derived CTLs have been shown to be safe and effective against a variety of viruses including CMV, EBV, BK and adenovirus. We hypothesize that SARS-CoV-2 specific CTLs generated from a previously infected family donor will be safe and effective for treatment of COVID-19 in family members with mild to moderate disease.
Official title: A Pilot Study of SARS-CoV-2 Specific Cytotoxic T Lymphocytes (SARS-CoV-2-CTLs) for Treatment of Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2021-09-20
Completion Date
2026-12-31
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Standard of Care
Patients will receive standard of care for COVID-19.
SARS-CoV2-CTLS
Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.
Locations (4)
New York Medical College
Valhalla, New York, United States
Nationwide Children's Hosptial
Columbus, Ohio, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States