Overview
Sponsor-declared trial summary
post-COVID syndrome (long COVID)
To assess whether we are able to visualize and quantify a difference in amyloid containing microclots between post-COVID patients and controls using total-body dynamic [18F]flutemetamol PET.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2026-05-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To assess whether we are able to visualize and quantify a difference in amyloid containing microclots between post-COVID patients and controls using total-body dynamic [18F]flutemetamol PET.
Secondary objectives 2
- To assess the association between amyloid-containing microclots on total-body dynamic [18F]flutemetamol PET with type and severity of post-COVID symptoms as assessed using questionnaires
- To assess the association between amyloid-containing microclots on total-body dynamic [18F]flutemetamol PET with cerebral blood flow as assessed using MRI.
Conditions and MedDRA coding
post-COVID syndrome (long COVID)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- The subject was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2.
- The subject is at least 12 months after being diagnosed with COVID-19.
- The subject is in the range 40-65 years of age (to ensure radiation safety).
- The subject has sufficient command of the Dutch language.
- The subject is able to undergo the (PET) scanning procedures.
Exclusion criteria 4
- The subject has other medical conditions linked to amyloid-formation, such as diabetes, rheumatoid arthritis or neurodegenerative disorders.
- The subject is unable to undergo scanning procedures due to for example claustrophobia, severe back pain or trypanophobia (fear of needles).
- The subject is using anti-coagulant drugs.
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- 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)).
Secondary endpoints 3
- Amyloid-containing microclot load (size and quantity) in blood.
- Questionnaire scores on presence and severity of (post-COVID) symptoms
- MRI-derived parameters on brain structure and function.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB33652 · Substance
- Active substance
- Flutemetamol (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Coordinating researcher
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Coordinating researcher
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 65 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522348-42-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF controls | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patients | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vizamyl | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2025-522348-42-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-09 | Netherlands | Acceptable 2026-05-07
|
2026-05-07 |