Long COVID19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Hyperpolarized xenon
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: Xenon 129
Other descriptive name: XENON
Concentration unit: l litre(s)
Concentration type: up to
Concentr
Sponsors
Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Long COVID19 group: • Aged 18 – 85 years. • Pre-menopausal women must be confirmed non-pregnant by an onsite test. • Previous COVID-19 confirmed with PCR or antibody test. • Persistent long COVID-19 symptoms o Fatigue, chest pain, dyspnea or tachycardia o MRC dyspnea score above 2. o Symptoms not explained by other diseases after work-up at the long-term COVID19 clinic. Previous COVID19 group without symptoms: • Aged 18 – 85 years. • Pre-menopausal women must be confirmed non-pregnant by an onsite test. • Previous COVID-19 confirmed with PCR or antibody test. • No persistent long COVID-19 symptoms. Healthy volunteers: • Aged 18 – 85 years. • Pre-menopausal women must be confirmed non-pregnant by an onsite test. • No history of COVID-19. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: • Smoker (ever and current). • A history of pulmonary embolism. • Contraindications for MRI: - Pacemaker, neurostimulator or cochlear implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Intracranial clips or coils - Cardiac pacemakers - Claustrophobia - Largest circumference including arms > 160 cm • Competing pulmonary or systemic diseases. - Mild asthma is allowed (no recent oral steroids, no recent admission, monotreatment). • Allergy to xenon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study lung gas uptake in long COVID19;Secondary Objective: NA;Primary end point(s): Lung gas uptake and structure assessed with hyperpolarized xenon MRI. ;Timepoint(s) of evaluation of this end point: After the scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical characteristics including lung function. ;Timepoint(s) of evaluation of this end point: In the weeks after the scan. | — |
Countries
Denmark
Contacts
Public ContactMR Research Center
Aarhus University
Outcome results
None listed