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)
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA * Age ≥18 to 65 years. AND * Proven infection with SARS-CoV-2, defined as detection of SARS-CoV-2 by RT-PCR from nasopharyngeal swab or lower respiratory tract specimen AND * Hospitalized at the time of enrollment AND * HLA Matched Family Related donor with recent SARS-CoV-2 infection is at least 10 days out from symptom onset. A negative result for COVID-19 by a diagnostic test is not necessary to qualify the donor AND * In Stage I or II of disease (mild or moderate) at the time of enrollment (Table 1) AND * ONE of the following high-risk conditions: * Chronic lung dise…
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 CollegeValhalla, New York
- Nationwide Children's HosptialColumbus, Ohio
- Children's Hospital of PennsylvaniaPhiladelphia, Pennsylvania
- Medical College of Wisconsin/Children's Hospital of WisconsinMilwaukee, Wisconsin