CD8+ T-cell PET/CT Imaging in COVID-19 Patients

NCT04874818 | Terminated DMC

• 2 other identifiers: NL76248.091.202020-005984-29
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphopenia Due to COVID-19; T-cell; PET Imaging

Keywords

COVID-19; lymphopenia; T-cells; PET imaging

Outcome Measures

Primary Outcomes (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.

  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

  18 months

Secondary Outcomes (3)

• Based on imaging

  18 months

• Based on laboratory parameters

  18 months

• Based on clinical characteristics

  18 months

Study Arms (2)

lymphopenia

lymphocyte counts (\<1.0 x10e9/L)

Diagnostic Test: [89Zr]Df-IAB22M2C PET/CT scan

normal lymphocyte numbers

lymphocyte counts ((1.0 - 3.5 x10e9/L))

Diagnostic Test: [89Zr]Df-IAB22M2C PET/CT scan

Interventions

[89Zr]Df-IAB22M2C PET/CT scan DIAGNOSTIC_TEST

PET imaging procedure

lymphopenia; normal lymphocyte numbers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ImaginAb, Inc.: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

COVID-19; Lymphopenia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 6, 2021
• Study Start: February 14, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 2, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)