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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Site contacts updated at 2 of 4 sites
    v5
  2. 2 versions Re-verified since Mar 24, 2023, no change to tracked fieldsv3-v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2021 to Sep 20, 2021
    • Study sites: 3 to 4
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04896606
Lead Sponsor New York Medical College
Collaborators: Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital
Conditions
(from sponsor)		 Covid19
Related terms COVID-19
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov