Metabolic MRI of patients with long-term symptoms after COVID19-infection

Metabolic MRI with hyperpolarized pyruvate in long-term COVID19 patients

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001031-72-DK

Enrollment

Registered

2021-03-04

Start date

2021-04-08

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term COVID19 symptoms MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862

Interventions

Product Name: Hyperpolarized [1-13C]pyruvate Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: SODIUM PYRUVATE Other descriptive name: SODIUM PYRUVATE Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Aged 18 – 85 years. • Previous COVID-19 confirmed with PCR or antibody test. • Persistent, post COVID-19 symptoms o From the brain (fatigue, headache, sensory disturbances or cognitive difficulties) OR o From the heart (chest pain, dyspnea or tachycardia) o Symptoms not explained by other diseases after the extensive work-up at long-term COVID19 clinic. 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: • Contraindications for MRI with contrast: - Chronic kidney disease (eGFR = 30 mL/min/1.73m2) - Heart failure with reduced ejection fraction - Significant obstructive lung disease or severe asthma - Pacemaker, neurostimulator or cholera 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 neurological, psychiatric, cardiac, liver or systemic diseases including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed) • Allergy to pyruvate

Design outcomes

Primary

Measure	Time frame
Main Objective: This project seeks to probe the potential of using hyperpolarized pyruvate MRI for detecting metabolic changes in the heart or brain of patients with long-term COVID19 symptoms. ;Secondary Objective: Not applicable;Primary end point(s): Brain or heart metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate and lactate.;Timepoint(s) of evaluation of this end point: After the scan.	—

Measure

Time frame

Main Objective: This project seeks to probe the potential of using hyperpolarized pyruvate MRI for detecting metabolic changes in the heart or brain of patients with long-term COVID19 symptoms. ;Secondary Objective: Not applicable;Primary end point(s): Brain or heart metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate and lactate.;Timepoint(s) of evaluation of this end point: After the scan.

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Secondary

Measure	Time frame
Secondary end point(s): Disease characterization and symptom burden from the patient records.;Timepoint(s) of evaluation of this end point: After the scan.	—

Countries

Denmark

Contacts

Public ContactThe MR Research Center

Aarhus University

cl@clin.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026