SARS-CoV-2 CTLS for Mild to Moderate COVID-19
This study is testing a treatment called SARS-CoV2-CTLS for people with mild to moderate COVID-19. This treatment uses special immune cells (cytotoxic T lymphocytes or CTLs) from a family member who has recently recovered from COVID-19. You would receive these cells along with the usual care for COVID-19. Researchers want to see if SARS-CoV2-CTLS is safe and how many side effects people experience over 12 weeks. To join, you must be 18-65 years old, have a confirmed COVID-19 infection, be hospitalized, and have a family member who has recovered from COVID-19 and can donate their cells. The study aims to enroll 50 participants.
- Study design
- This interventional study plans to enroll 50 participants. It compares standard COVID-19 care with standard care plus SARS-CoV2-CTLS infusions.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events (side effects) for 12 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04896606
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Recruiting
PHASE1Ages 18–65InterventionalTreatmentNew York Medical CollegeInvestigator-initiated
~50 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Standard of CareSARS-CoV2-CTLS
At a glance
Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over 12 weeks
Conditions
Where it's being run
4 sites across 4 statesNew York1
Ohio1
Pennsylvania1
Wisconsin1
Study leadership
- Mitchell S Cairo, MD · STUDY_CHAIR · New York Medical College
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 disease not requiring oxygen at home prior to admission (including but not limited to COPD, cystic fibrosis, asthma and sickle cell disease); Underlying heart disease (including hypertension); Patients with an acute myocardial infarction within the last 3 months will require cardiology clearance prior to enrollment; Diabetes mellitus (type I or II) ; Obesity (BMI ≥ 30); Immunosuppressed, based on investigator's assessment.
Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of enrollment
Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL Infusion
Patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded
Patients with stage D heart failure and/or symptoms at rest are excluded
Renal function: patients with eGFR or CrCl \<30 mL/min/1.73 m2 will be excluded from study entry.
Liver function: Total bilirubin \> 2 mg/dl (unless Gilbert's syndrome) OR ALT/AST \> 5 x ULN
Patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study
Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤50%
Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of SARS-CoV-2 CTLS.
Male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of SARS-CoV-2 CTLS.
Concurrent use of following medications is prohibited:
Steroids (\>2 mg/kg/day prednisone equivalent); Immunotherapies within 4 weeks prior to CTL infusion including checkpoint blockade, ATG, Campath, CAR T cells, blinatumomab; Chemotherapy: Tyrosine kinase inhibitors and hydroxyurea must be stopped \> 72 hours prior to SARS-COV-2-CTL cell infusion; High dose chemotherapy must be stopped \> 2 weeks prior to SARS-CoV-2-CTLs. High dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; Pegylated-asparaginase must be stopped \> 4 weeks prior to SARS-COV-2-CTL infusion; Intrathecal chemotherapy must be stopped \> 1 week prior to SARS-COV-2-CTL infusion (e.g. intrathecal methotrexate); Anti T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to SARS-CoV-2-CTLs is prohibited.
Exclusion
Stage III disease (severe) at the time of enrollment (see Table 1)
Lack of an identified eligible HLA family related donor
What this trial measures
- Incidence of adverse events12 weeks
no adverse events will occur due to CTL infusion(s)