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Trial record 1 of 1 for:    nct04874818
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CD8+ T-cell PET/CT Imaging in COVID-19 Patients (Tangelo)

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ClinicalTrials.gov Identifier: NCT04874818
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
ImaginAb, Inc.
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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Brief Summary:
A subset of patients diagnosed with severe acute respiratory syndrome (SARS)-CoV2 infection present with lymphopenia. The degree of lymphopenia, and in particular reduced cluster of differentiation (CD)8+ T-cell numbers, is correlated with clinical deterioration and intensive care unit (ICU) admission. The underlying reasons for lymphopenia in coronavirus disease (COVID)-19 is currently unclear, We aim to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV2 presenting with lymphopenia or with normal lymphocyte counts, using Zirconium-89 ([89Zr])Df-IAB22M2C positron emission tomography (PET) imaging.

Condition or disease Intervention/treatment
Lymphopenia Due to COVID-19 T-cell PET Imaging Diagnostic Test: [89Zr]Df-IAB22M2C PET/CT scan

Detailed Description:

Rationale: A subset of patients diagnosed with SARS-CoV2 infection present with lymphopenia. The degree of lymphopenia, and in particular reduced CD8+ T-cell numbers, is strongly correlated with clinical deterioration and ICU admission .

The underlying reasons for lymphopenia in COVID-19 is currently unclear, but several hypotheses have been put forward; 1) sequestration of CD8+ T-cells in peripheral tissues (e.g. lung) either during the effector phase of their lifespan or passively by local chemotactic signals, 2) accelerated maturation and apoptosis either induced by storm of inflammatory cytokines or direct infection or 3) resulting from decreased lymphopoiesis induced by reduced levels of stem cell factor. The lack of data on in vivo distribution of CD8+ T-cells hampers a more thorough understanding of this critical prognostic factor.

Aim: We aim to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV2 presenting with lymphopenia or with normal lymphocyte counts, using [89Zr]Df-IAB22M2C PET/CT imaging.

Study design: This is a prospective, observational non-randomized pilot study in 20 patients with microbiologically proven SARS-CoV2 infection. All patients will undergo a whole body [89Zr]Df-IAB22M2C PET/CT scan.

Study population: Twenty patients ≥50 years of age with proven COVID-19, who are admitted to the ward will be included, patients will be stratified according to lymphocyte counts on admission to ensure an even distribution: presenting with lymphopenia (<1.0 x10e9/L) (n=10) and with lymphocyte numbers within normal range (1.0 - 3.5 x10e9/L) (n=10).

Study procedure: All patients will undergo a [89Zr]Df-IAB22M2C PET/CT scan 21-27 hours post intravenous injection of 1.5mg protein dose labelled with 37 megabecquerel (MBq) (1 mCi) 89Zr; and one additional blood sample at the day of scanning.

Primary study objective: The primary objective of this study is to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts, using [89Zr]Df-IAB22M2C PET/CT imaging.

Secondary study objectives:

  1. To assess the spatial correlation between [89Zr]Df-IAB22M2C uptake and abnormal findings on routine contrast-enhanced CT scan of the chest
  2. To assess the correlation between in vivo biodistribution of [89Zr]Df-IAB22M2C and concurrent flowcytometric phenotypic and quantitative assessment of lymphocyte populations
  3. To explore the correlation between in vivo biodistribution of [89Zr]Df-IAB22M2C and clinical course of disease
Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: [89Zr]Df-IAB22M2C Anti-CD8 Minibody PET/CT Imaging to Assess the in Vivo Distribution of CD8+ T-cells in COVID-19 Patients
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
lymphopenia
lymphocyte counts (<1.0 x10e9/L)
 Diagnostic Test: [89Zr]Df-IAB22M2C PET/CT scan
PET imaging procedure
normal lymphocyte numbers
lymphocyte counts ((1.0 - 3.5 x10e9/L))
 Diagnostic Test: [89Zr]Df-IAB22M2C PET/CT scan
PET imaging procedure


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this study is to quantify uptake of [89Zr]Df-IAB22M2C, as a surrogate for the presence of CD8+ T-cells, in major organ systems of patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts. [ Time Frame: 18 months ]
    The main study parameter is the SUVmean uptake of [89Zr]Df-IAB22M2C in major organs systems, e.g. lungs, spleen, bone marrow, liver and bloodpool


Secondary Outcome Measures :
  1. Based on imaging [ Time Frame: 18 months ]
    1) Spatial correlation of SUVmean per lung segment with CORADS score per lung segment

  2. Based on laboratory parameters [ Time Frame: 18 months ]
    2) In vivo biodistribution of [89Zr]Df-IAB22M2C will be correlated to laboratory test 3) In vivo biodistribution of [89Zr]Df-IAB22M2C will be correlated with lymphocyte counts (x10e9/L)

  3. Based on clinical characteristics [ Time Frame: 18 months ]
    4) In vivo biodistribution of [89Zr]Df-IAB22M2C will be correlated with duration of hospital stay (days)


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population for this pilot study exists of 20 evaluable patients with a proven SARS-CoV2 infection admitted to the Infectious Diseases ward. Patients presenting in the Radboud University Medical Center will be considered for recruitment.
Criteria

Inclusion Criteria:

  • a microbiologically proven SARS-CoV2 infection
  • More than 50 years of age;
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Contra-indication for PET: Pregnancy, Breast-feeding, Severe claustrophobia.
  • Contra-indication for administration of iodine-containing contrast agents
  • Other serious illness, e.g. history of malignancies or auto-immune disorders
  • Known pre-existing lymphopenia from an unrelated other medical condition
  • Estimated creatinine clearance ≤ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) OR oligo-uric patients (<400 mL/24hr)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874818


Contacts
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Contact: Erik Aarntzen, PhD, MD +31(0)243614840 erik.aarntzen@radboudumc.nl
Contact: Michel De Groot +31(0)243614840 michel.degroot@radboudumc.nl

Locations
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Netherlands
Radboud university medical center Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Erik Aarntzen, MD, PhD         
Sponsors and Collaborators
Radboud University Medical Center
ImaginAb, Inc.
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT04874818    
Other Study ID Numbers: NL76248.091.20
2020-005984-29 ( EudraCT Number )
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
COVID-19
lymphopenia
T-cells
PET imaging
Additional relevant MeSH terms:
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COVID-19
Lymphopenia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases