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

Part of paid clinical trials in Valhalla, New York.

Sponsor
New York Medical College
Study ID
NCT04896606
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care — OTHER
    Patients will receive standard of care for COVID-19.
  • SARS-CoV2-CTLS — BIOLOGICAL
    Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.

Study Details

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.

Key Dates

Start date
Sep 20, 2021
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Standard of Care Only
    Patients will NOT received COVID CTLs but will get standard of care.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 12 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
New York Medical CollegeValhallaNew York10595
Lauren Harrison, MSN, RN
[email protected]
617-285-7844
Elizabeth Mintzer
[email protected]
Nationwide Children's HosptialColumbusOhio43205
Dean Lee, MD, PhD
[email protected]
(614) 722-3550
Children's Hospital of PennsylvaniaPhiladelphiaPennsylvania19104
Nancy Bunin, MD
[email protected]
215 590-2255
Medical College of Wisconsin/Children's Hospital of WisconsinMilwaukeeWisconsin53226
Julie A Talano, MD
[email protected]
414-955-4185
Kathy Jodarski
[email protected]
414-266-2681

Find similar trials in Valhalla, NY

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
New York Medical College· Valhalla, NYNationwide Children's Hosptial· Columbus, OHChildren's Hospital of Pennsylvania· Philadelphia, PAMedical College of Wisconsin/Children's Hospital of Wisconsin· Milwaukee, WI

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