Overview
Sponsor-declared trial summary
post-COVID syndrome
To assess differences between participants with persistent post-COVID complaints and controls without persistent post-COVID complaints in cellular metabolism in the brain as measured with dynamic [18F]FDG PET, structural and functional brain parameters as assessed with MRI, and immune-related blood parameters.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2026-06-01
- 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, Diagnosis
To assess differences between participants with persistent post-COVID complaints and controls without persistent post-COVID complaints in cellular metabolism in the brain as measured with dynamic [18F]FDG PET, structural and functional brain parameters as assessed with MRI, and immune-related blood parameters.
Conditions and MedDRA coding
post-COVID syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- The subject was diagnosed with mild symptomatic COVID-19, confirmed by a positive PCR for SARS- CoV-2, positive SARS-CoV-2 serology or CO-RADS (COVID-19 Reporting and Data System) 4 or 5 on CT-scan, or antigen quicktest, or had typical symptoms and was part of a household in which another person was tested positive by PCR 2 weeks before or after the first day of illness
- The subject is at least one year after being diagnosed with COVID-19
- Subjects with persistent post-COVID complaints experience severe levels of fatigue (≥ 35) on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue]) and/or difficulty concentrating (≥18) on the concentration subscale of the Checklist Individual Strength [CIS-concentration]. Control subjects without persistent complaints experiences no fatigue (<35) on the CIS-fatigue and no difficulty concentrating (<18) on the CIS-concentration
- The subject is in the range 30-65 years of age
- The subject has sufficient command of the Dutch language
Exclusion criteria 4
- The subject is unable to lay still for scanning due to claustrophobia, severe back pain or trypanophobia (fear of needles)
- The subject is of female sex with childbearing potential and not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must orally and in writing confirm not to be pregnant or breastfeeding at the time of screening and at the day of the PET scan
- The subject has an already known psychiatric, somatic or neurodegenerative condition that can explain his/her complaints
- The subject is actively using anti-inflammatory drugs
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Cellular metabolism in the brain as measured with dynamic [18F]FDG PET
- Structural and functional parameters of the brain as measured with MRI
- Immune-related blood parameters
Secondary endpoints 1
- Presence and severity of symptoms as measured with questionnaires
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Fludeoxyglucose (18F)-Curium, 185 MBq/ml oplossing voor injectie.
PRD315853 · Product
- Active substance
- Fludeoxyglucose (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 198 MBq megabecquerel(s)
- Max total dose
- 198 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- RVG 29834
- MA holder
- CURIUM INTERNATIONAL
- MA country
- Netherlands
- 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
- Denise Visser
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Denise Visser
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 2025-522349-23-00 | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF controles | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF patienten | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC FDG-Curium | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis NL 2025-522349-23-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-19 | Netherlands | Acceptable 2026-06-01
|
2026-06-01 |