Clinical trial • Not applicable • Infectious Disease

FLUTEMETAMOL (18F) for Post-COVID syndrome (Long COVID)

Not applicable trial of FLUTEMETAMOL (18F) for Post-COVID syndrome (Long COVID).

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Post-COVID syndrome (Long COVID)
Trial Stage
Not applicable
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
09-02-2026
First CTIS Authorization Date
07-05-2026

Trial design

Healthy volunteers (control group); no active drug comparator or dosing described. Not applicable trial in Netherlands.

Comparator
Healthy volunteers (control group); no active drug comparator or dosing described.
Target Sample Size
65

Eligibility

Recruits 65 No vulnerable population selected. Participants are adults (40-65 years). Informed consent is required from each participant; no assent or special vulnerable-population consent procedures are described..

Pregnancy Exclusion
The subject is a female of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
Vulnerable Population
No vulnerable population selected. Participants are adults (40-65 years). Informed consent is required from each participant; no assent or special vulnerable-population consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- The subject was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2.\n- The subject is at least 12 months after being diagnosed with COVID-19.\n- The subject is in the range 40-65 years of age (to ensure radiation safety).\n- The subject has sufficient command of the Dutch language.\n- The subject is able to undergo the (PET) scanning procedures."}

Exclusion criteria

  • {"criterion_text":"- The subject has other medical conditions linked to amyloid-formation, such as diabetes, rheumatoid arthritis or neurodegenerative disorders.\n- The subject is unable to undergo scanning procedures due to for example claustrophobia, severe back pain or trypanophobia (fear of needles).\n- The subject is using anti-coagulant drugs.\n- The subject is a female of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Quantitative measures of [18F]Flutemetamol binding throughout the body of participants, expressed in parameters such as volume of distribution (VT) or non displaceable binding potential (BPND) (depending on the most suitable kinetic model per region or tissue of interest (ROI)).","definition_or_measurement_approach":"Quantitative PET measures of [18F]Flutemetamol binding expressed as parameters such as volume of distribution (VT) or non-displaceable binding potential (BPND), using the most suitable kinetic model per region/tissue of interest (ROI)."}

Secondary endpoints

  • {"endpoint_text":"- Amyloid-containing microclot load (size and quantity) in blood.\n- Questionnaire scores on presence and severity of (post-COVID) symptoms\n- MRI-derived parameters on brain structure and function.","definition_or_measurement_approach":"Amyloid-containing microclot load measured in blood (size and quantity); symptom severity assessed by questionnaire scores; MRI-derived parameters of brain structure and function as obtained from MRI protocols."}

Recruitment

Planned Sample Size
65
Recruitment Window Months
10
Consent Approach
Informed consent obtained from each participant. Subject information and informed consent forms are available (separate for patients and controls). Participants must have sufficient command of Dutch, indicating consent documents/interactions in Dutch; no additional assent or alternative-language procedures are described.

Geography

Total Number Of Sites
1
Total Number Of Participants
65

Netherlands

Earliest CTIS Part Ii Submission Date
27-04-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
10
Number Of Sites
1
Number Of Participants
65

Sites

Site Name
Amsterdam UMC Stichting - De Boelelaan 1117
Department Name
Radiology & Nuclear Medicine
Contact Person Name
Ronald Boellaard
Contact Person Email
r.boellaard@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Patient organisation/association
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
FLUTEMETAMOL (18F)
Active Substance
FLUTEMETAMOL (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Authorised

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