Clinical Trial

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

Recruiting Phase 1/2
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-05-19; most recent amendment 2026-04-10.
Status change: Not Yet Recruiting → Recruiting 2022-01-10
Trial Details
NCT Number NCT04896606
Lead Sponsor New York Medical College
Collaborators: Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital
Conditions Covid19
Enrollment 50 participants
Start Date 2021-09-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13