Actively Recruiting
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Led by New York Medical College · Updated on 2026-04-13
50
Participants Needed
4
Research Sites
275 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Confirmed infection with SARS-CoV-2 by PCR from nasopharyngeal or lower respiratory tract sample
- Hospitalized at the time of enrollment
- Have an HLA matched family donor with recent SARS-CoV-2 infection at least 10 days after symptom onset
- Currently in Stage I or II (mild or moderate) COVID-19 disease
- Have at least one high-risk condition including chronic lung disease without oxygen at home, heart disease, recent myocardial infarction with clearance, diabetes, obesity (BMI ≥ 30), or immunosuppression based on investigator assessment
You will not qualify if you...
- Stage III (severe) COVID-19 disease at enrollment
- No eligible HLA matched family donor identified
- No high-risk comorbidities as defined in inclusion
- Acute graft-versus-host disease grade > 2 or extensive chronic GVHD
- Received donor lymphocyte infusion within 4 weeks prior to CTL infusion
- Chronic respiratory failure requiring ventilator or home oxygen prior to admission
- Stage D heart failure or symptoms at rest
- Renal function with eGFR or creatinine clearance < 30 mL/min/1.73 m2
- Liver function with total bilirubin > 2 mg/dl (unless Gilbert's syndrome) or ALT/AST > 5 times upper limit
- Currently listed for or eligible for organ transplant
- Poor performance status with Karnofsky or Lansky score ≤ 50%
- Pregnant or breastfeeding women or unwilling to use birth control during and 6 weeks after treatment
- Male partners of women of childbearing potential unwilling to use birth control during and 6 weeks after treatment
- Use of prohibited medications including high-dose steroids, recent immunotherapies, certain chemotherapies, or T-cell antibodies within specified timeframes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
2
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Not Yet Recruiting
3
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
4
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
M
Mitchell S Cairo, MD
CONTACT
L
Lauren Harrison, RN, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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