Xenon lung MRI in long-term COVID19

Phase 1

• Conditions: ong COVID19; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2021-006335-26-DK
• Lead Sponsor: Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-22
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 32

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
oFatigue, chest pain, dyspnea or tachycardia
oMRC dyspnea score above 2.
oSymptoms 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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical characteristics including lung function. ;Timepoint(s) of evaluation of this end point: In the weeks after the scan.