Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruiting
Participants planned
60
Countries
1
Sites
1
post-acute sequelae of COVID-19
To assess if pulmonary fibroblast activity, measured by [68Ga]FAPI-PET/CT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 1 Jul 2025 → ongoing
- Decision date (initial)
- 2025-01-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To assess if pulmonary fibroblast activity, measured by [68Ga]FAPI-PET/CT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints.
Secondary objectives 3
- To compare whole body FAP uptake in patients with persistent vs resolved long COVID complaints
- To compare FAP uptake to clinical endpoints (e.g. lung function, 6-minute walking test (6-MWT), and self-reported daily impairments assessed by several questionnaires).
- To explore serum biomarkers (e.g. soluble FAP and cytokines/growthfactors) and cellular phenotypes of inflammation and remodelling in relation to FAP uptake.
Conditions and MedDRA coding
post-acute sequelae of COVID-19
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-006797-24 | [68]Ga-FAPI PET/CT to detect ongoing fibroblast activity in post-acute COVID-19 with respiratory impairment after hospital discharge: “The FAPI COVID-CLIMATE Study” |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adult patients > 20 years
- Self-reported complaints of dyspnea or fatigue > 3 months after SARS-CoV-2 infection confirmed with PCR, serology test or COVID-19 Reporting and Data System (CO-RADS) score 4/5.
- Group 1: Fatigue Severity Scale ≥ 4 at time of [68Ga]FAPI PET/CT
- Group 2: Fatigue Severity Scale < 4 at time of [68Ga]FAPI PET/CT after having previously recorded score of ≥ 4 or equivalent.
- In addition, when insufficient when insufficient subjects can be included in group 2 ‘Healthy’ controls will be included from the Lifelines or PARASOL cohort with the following criteria: Patients without self-reported complaints and past SARS-CoV-2 infection (which would have resulted in a Fatigue Severity Scale < 4) or without experienced confirmed SARS-CoV-2 infection.
Exclusion criteria 2
- Inability or unwilling to give informed consent.
- History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- TBRLung (Target to background ratio of the lung) differences per group
Secondary endpoints 5
- SUVmean and SUVmax of both paravertebral muscles
- [68Ga]FAPI uptake (SUVmean) vs % of ground galss opacities (GGO) on high resolution CT
- [68Ga]FAPI uptake (SUVmean) related to the outcome of multiple questionnaires.
- [68Ga]FAPI uptake (SUVmean) related to patience health metrics (lung function and 6-MWT)
- [68Ga]FAPI uptake (SUVmean) related to biology (circulating extra cellular matrix fragments, circulating soluble FAP, inflammatory blood markers and systemic and upper respiratory tract cellular phenotypes)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11595253 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Substance synonyms
- 68Ga-FAPI-46
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 220 MBq/ml megabecquerel(s)/millilitre
- Max total dose
- 220 MBq/ml megabecquerel(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY MEDICAL CENTER GRONINGEN
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Intensive Care research desk
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Intensive Care research desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University Medical Center Groningen
Critical Care, Hanzeplein 1, 9713 GZ, Groningen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-07-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_Appendix1_Diffusiecapaciteitsmeting Functiecentrum en Allergologie_V2_UMCG_NLD_NLD | 2 |
| Protocol (for publication) | D1_Protocol_Appendix2_Flow volumemeting Functiecentrum Longfunctie en Allergologie_V3_UMCG_NLD_NLD | 3 |
| Protocol (for publication) | D1_Protocol_Appendix3_Radiation Exposure HRCT_redacted | 1 |
| Protocol (for publication) | D1_Protocol_Appendix4_Radiation_safety_statement_LIBERATE_Quadra_redacted | 1 |
| Protocol (for publication) | D1_Protocol_Appendix5_Radiation_safety_statement_LIBERATE_Vision_Redacted | 1 |
| Protocol (for publication) | D1_Protocol_LIBERATE_UMCG_NLD_ENG_redacted | 5.0 |
| Protocol (for publication) | D4_Appendix_6_Instructies faeces verzamelen | 1 |
| Protocol (for publication) | D4_Q1_DSQ-PEM short form | 1 |
| Protocol (for publication) | D4_Q2_EuroQol 5D-5L | 1 |
| Protocol (for publication) | D4_Q3_Fatigue Severity Scale | 1 |
| Protocol (for publication) | D4_Q4_Medical Research Council MRC Dyspnoe vragenlijst | 1 |
| Protocol (for publication) | D4_Q5_Utrechtse Schaal voor Evaluatie van Revalidatie-Participatie | 1 |
| Protocol (for publication) | D4_Q6_Vragenlijst ziektevoortgang en ongewenste voorvallen | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_procedure_UMCG_NLD_ENG | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_procedure_UMCG_NLD_ENG_2024-517931-29-00 SM-1 TC | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Material_Flyer_NLD_2024-517931-29-00 SM-1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Material_Letter_Patient_Associations_NLD_2024-517931-29-00 SM-1 Track_Changes | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Material_Letter_Patient_Associations_NLD_2024-517931-29-00 SM-1 v2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_LIBERATE_UMCG_NLD_NLD_redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_V1_UMCG_NLD_NLD | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-24 | Netherlands | Acceptable 2025-01-20
|
2025-01-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-28 | Netherlands | Acceptable 2025-01-20
|
2025-01-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-15 | Netherlands | Acceptable 2025-09-22
|
2025-09-22 |