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RECRUITING
NCT04896606
PHASE1/PHASE2

SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease

Sponsor: New York Medical College

View on ClinicalTrials.gov

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

OTHER

Standard of Care

Patients will receive standard of care for COVID-19.

BIOLOGICAL

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