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Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19

NCT04762186 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-09-15

No results posted yet for this study

Summary

Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC

Conditions

  • Moderate COVID-19-infection

Interventions

DRUG

human SARS-CoV 2 specific T lymphocytes

In dose level one, SARS-CoV-2 infected patients will receive 1,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In dose level two SARS-CoV-2 infected patients will receive 5,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In parallel, all patients will receive the current SoC treatment for COVID-19.

Sponsors & Collaborators

  • ZKS Köln

    collaborator OTHER

  • Hannover Medical School

    collaborator OTHER

  • Miltenyi Biomedicine GmbH

    collaborator INDUSTRY

  • Universitätsklinikum Köln

    lead OTHER

Principal Investigators

  • Philipp Köhler, Dr. · Department I for Internal Medicine University Hospital of Cologne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2022-08-03
Completion
2022-08-03

Countries

  • Germany

Study Locations

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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 NCT04762186 on ClinicalTrials.gov