NCT04896606 · New York Medical College
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
What this study 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 the usual treatment or FDA approved therapies for treatment of COVID-19.
View original scientific description
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.
Interventions
OTHER
Standard of Care
Patients will receive standard of care for COVID-19.
BIOLOGICAL
SARS-CoV2-CTLS
Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.
Primary outcome measures
Incidence of adverse events
Time frame: 12 weeks
no adverse events will occur due to CTL infusion(s)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 inve
Where
- Valhalla, New York
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Milwaukee, Wisconsin
Collaborators
Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations