E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and pulmonary abnormalities on contrast-enhanced CT undergo static PET scans after injection of 70 μg (200 MBq) [68Ga]Ga-DOTA-(RGD)2. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with proven COVID-19 infection and pulmonary abnormalities. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10047468 |
E.1.2 | Term | Viral lower respiratory tract infections |
E.1.2 | System Organ Class | 100000004855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10047483 |
E.1.2 | Term | Viral upper respiratory tract infections |
E.1.2 | System Organ Class | 100000004855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038701 |
E.1.2 | Term | Respiratory insufficiency |
E.1.2 | System Organ Class | 100000004855 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to demonstrate and quantitate aberrant activation of the endothelium in the lung vasculature using [68Ga]Ga-DOTA-(RGD)2 PET/CT. |
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E.2.2 | Secondary objectives of the trial |
1) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on contrast-enhanced CT scan of the chest
2) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and subtraction CT of the chest
3) To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and blood-based biomarkers (BioMarCo-19 study, CMO 2020-6344)
4) To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• A microbiologically proven SARS-CoV-19 infection;
• Pulmonary involvement as demonstrated on recent (<1 week) chest CT;
• Enrolled in the BioMarCo-19 study (CMO2020-6344);
• More than or equal to 18 years of age;
• Ability to provide written informed consent.
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E.4 | Principal exclusion criteria |
• Contra-indication for PET:
o Pregnancy;
o Breast-feeding;
o Severe claustrophobia.
• Contra-indication for administration of iodine-containing contrast agents;
• Other serious illness, e.g. history of malignancies
;• Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is the uptake of [68Ga]Ga-DOTA-(RGD)2 in the lesions as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) spatial correlation (per lung segment) with ground-glass opacities, consolidation, vessel size and other components of CORADS system;
2) spatial correlation (per lung segment) with perfusion abnormalities as measured by subtraction CT;
3) quantitative correlation with blood counts and differentiation, ferritin, D-dimer, CRP, liver enzyme panel (ALAT, ASAT, direct and indirect bilirubin, alkaline phosphatase, gamma-GT, LDH), cytokines, as obtained by approved study BioMarCo-19 (CMO 2020-6344);
4) correlation with the following clinical parameters: ICU admission, mechanical ventilation parameters, oxygen demand, length of ICU stay (days), length of hospital stay (days).
Additional study parameters are uptake in the myocardium and the lung-to-background ratio (LBR).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |