RecruitingPhase 1Phase 2NCT04896606

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

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)


Sponsor

New York Medical College

Enrollment

50 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called SARS-CoV2-CTLS and Standard of Care for people with covid19. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard of Care

Patients will receive standard of care for COVID-19.

BIOLOGICALSARS-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

View Full Details on ClinicalTrials.gov

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NCT04896606


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