Pilot Study of SARS-CoV-2 Specific Cytotoxic T Lymphocytes for Treating Mild to Moderate COVID-19 in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating a treatment for mild to moderate COVID-19 using SARS-CoV-2 specific cytotoxic T lymphocytes CTLs derived from family donors who had previously been infected. This pilot study aims to assess the safety and potential effectiveness of these CTLs combined with standard care, as there is currently no FDA-approved therapy for COVID-19. The study involves adults aged 18 to 65 who are hospitalized with confirmed SARS-CoV-2 infection and at higher risk due to certain medical conditions. Participants are randomly assigned to one of two groups one group receives up to five infusions of family donor-derived SARS-CoV-2 CTLs every two weeks alongside standard care, while the other group receives only standard care for COVID-19. The donor must be HLA matched, recovered from COVID-19 at least 10 days prior, and need not have a negative COVID-19 test. The study includes phases 1 and 2 to evaluate safety and response. During the 12-week study period, participants are monitored for adverse events as the primary outcome measure. Safety assessments and clinical evaluations occur regularly to track responses and side effects. The research team collects data on the incidence of adverse events and overall participant health while receiving the infusions and standard care. The study is sponsored by New York Medical College and runs until the end of 2026.

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