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

NCT04896606 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Covid19

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.

Sponsors & Collaborators

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • New York Medical College

    lead OTHER

Principal Investigators

  • Mitchell S Cairo, MD · New York Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896606 on ClinicalTrials.gov