COVID-19
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients must meet all of the following criteria: 1. microbiologically proven SARS-CoV-19 infection; 2. More than or equal to 18 years of age; 3. Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: A patient will be excluded from participation in the trial if one or more of the following criteria are met: 1. Contra-indication for PET; pregnancy, breast-feeding, severe claustrophobia 2. Contra-indication for administration of iodine-containing contrast agents 3. Other serious illness, e.g. history of malignancies or auto-immune disorders 4. Known pre-existing lymphopenia from an unrelated other medical condition 5. Estimated creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the whole body in vivo biodistribution of [89Zr]Df-IAB22M2C as quantified by PET/CT. All main organs will automatically be segmented using Siemens MIWBAS. The following parameters will be calculated and reported in a descriptive fashion: SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD, total organ activity (% of total measured activity). Statistical tests to assess group differences will include the non-parametric Mann-Whitney U test per organ, since normal distribution cannot be assumed. Overall distribution profiles will be tested using Chi-square test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Imaging related: 1) Spatial correlation (per lung segment) with ground-glass opacities, consolidation and vascular thickening Biomarker related: 2) Absolute and relative organ uptake of [89Zr]Df-IAB22M2C will be quantitatively correlated with concurrent levels of ferritin, D-dimer, CRP, as obtained per routine clinical care using Spearman non-parametric correlation. 3) Absolute and relative organ uptake of [89Zr]Df-IAB22M2C will be quantitatively correlated with total lymphocyte numbers, absolute and relative numbers of CD4+ and CD8+ T-cells using Spearman non-parametric correlation, as well as descriptively correlated with flowcytometric markers (PD-1, TIM-3, Granzyme B/CD127, phenotyping (CD45RA/CCR7, or CD62L/CD28) to establish effector memory/central memory, naïve and TEMRA subsets) Clinical outcome related: 4) Absolute and relative organ uptake of [89Zr]Df-IAB22M2C will be correlated with the following clinical parameters: (time to) eventual ICU admission, length of ICU stay (days), mechanical ventilation parameters, oxygen demand, total length of hospital stay (days). | — |
Countries
Netherlands
Outcome results
None listed