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Safety Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in COVID-19 pnEumonia or Lymphopenia

NCT04578210 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-06-01

No results posted yet for this study

Summary

This is a phase I/II clinical trial using adoptive cell therapy with NK cells or memory T cells in patients affected by COVID-19.

Severe cases with COVID-19 present a dysregulated immune system with T cell lymphopenia, specially NK cells and memory T cells, and a hyper-inflammatory state.

This clinical trial proposes the use of cell therapy for the treatment of patients with worse prognosis due to SARS-CoV-2 infection (those with pneumonia and/or lymphopenia). This is an innovative and a non-pharmacological intervention.

Conditions

  • Corona Virus Infection

Interventions

BIOLOGICAL

T memory cells and NK cells

Single infusion of NK or memory T cells from a healthy donor recovered from COVID-19 (dose escalation).

Sponsors & Collaborators

  • Universidad Autonoma de Madrid

    collaborator OTHER

  • Universidad Miguel Hernandez de Elche

    collaborator OTHER

  • Biocruces Bizkaia Health Research Institute

    collaborator OTHER_GOV

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    collaborator OTHER

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2022-01-13
Completion
2022-03-30

Countries

  • Spain

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 NCT04578210 on ClinicalTrials.gov