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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04896606
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : March 27, 2023
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Medical College of Wisconsin
Nationwide Children's Hospital
Information provided by (Responsible Party):
New York Medical College

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Other: Standard of Care Biological: SARS-CoV2-CTLS Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A run-in pilot will be done treating patients with COVID CTLs for safety. If there are no DLTs per definition in the study, study will proceed with a randomized trial of COVID CTLs + standard of care versus just standard of care alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SARS-CoV-2 CTLS + Standard of Care
Patients will get family donor derived SARS-CoV-2 cytotoxic t-lymphocytes up to 5 times every 2 weeks along with Standard of care of COVID-19.
 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.
Active Comparator: Standard of Care Only
Patients will NOT received COVID CTLs but will get standard of care.
 Other: Standard of Care
Patients will receive standard of care for COVID-19.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 12 weeks ]
    no adverse events will occur due to CTL infusion(s)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 investigator's assessment.

EXCLUSION CRITERIA:

  • Stage III disease (severe) at the time of enrollment (see Table 1)
  • Lack of an identified eligible HLA family related donor
  • No high-risk comorbidities defined in the inclusion criteria (Section 5.1)
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896606


Contacts
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Contact: Mitchell S Cairo, MD 9145942150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, RN, MSN 16172857844 lauren_harrison@nymc.edu

Locations
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United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Lauren Harrison, MSN, RN    617-285-7844    lauren_harrison@nymc.edu   
Contact: Elizabeth Mintzer       emintzer2@nymc.edu   
United States, Ohio
Nationwide Children's Hosptial Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Dean Lee, MD, PhD    614-722-3550    Dean.Lee@nationwidechildrens.org   
United States, Pennsylvania
Children's Hospital of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nancy Bunin, MD    215-590-2255    buninn@email.chop.edu   
United States, Wisconsin
Medical College of Wisconsin/Children's Hospital of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Julie A Talano, MD    414-955-4185    jtalano@mcw.edu   
Contact: Kathy Jodarski    414-266-2681    kjodarski@chw.org   
Sponsors and Collaborators
New York Medical College
Children's Hospital of Philadelphia
Medical College of Wisconsin
Nationwide Children's Hospital
Investigators
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Study Chair: Mitchell S Cairo, MD New York Medical College
More Information
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Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT04896606    
Other Study ID Numbers: NYMC 604
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases