(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Post-acute sequelae of COVID-19 (Long COVID)

Inclusion criteria

• {"criterion_text":"- Adult patients > 20 years\n- 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.\n- Group 1: Fatigue Severity Scale ≥ 4 at time of [68Ga]FAPI PET/CT\n- Group 2: Fatigue Severity Scale < 4 at time of [68Ga]FAPI PET/CT after having previously recorded score of ≥ 4 or equivalent.\n- 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

• {"criterion_text":"- Inability or unwilling to give informed consent.\n- History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans."}

Primary endpoints

• {"endpoint_text":"- TBRLung (Target to background ratio of the lung) differences per group","definition_or_measurement_approach":"TBRLung = target-to-background ratio of the lung measured on [68Ga]FAPI-PET/CT; comparison of TBRLung between groups."}

Secondary endpoints

• {"endpoint_text":"- SUVmean and SUVmax of both paravertebral muscles","definition_or_measurement_approach":"Standardized uptake values (SUVmean, SUVmax) measured on [68Ga]FAPI-PET/CT of paravertebral muscles."}
• {"endpoint_text":"- [68Ga]FAPI uptake (SUVmean) vs % of ground galss opacities (GGO) on high resolution CT","definition_or_measurement_approach":"[68Ga]FAPI uptake (SUVmean) measured by PET compared to percentage of ground glass opacities on high-resolution CT."}
• {"endpoint_text":"- [68Ga]FAPI uptake (SUVmean) related to the outcome of multiple questionnaires.","definition_or_measurement_approach":"Correlation of PET SUVmean with patient-reported outcomes assessed via questionnaires (e.g. Fatigue Severity Scale and others listed in protocol attachments)."}
• {"endpoint_text":"- [68Ga]FAPI uptake (SUVmean) related to patience health metrics (lung function and 6-MWT)","definition_or_measurement_approach":"Association of PET SUVmean with clinical measures including lung function tests and 6-minute walking test (6-MWT)."}
• {"endpoint_text":"- [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)","definition_or_measurement_approach":"Association of PET SUVmean with blood biomarker assays (circulating ECM fragments, soluble FAP, inflammatory markers) and cellular phenotyping."}

Methods

• Recruitment via University Medical Center Groningen (site-based recruitment) using local recruitment procedure (K1_Recruitment_procedure_UMCG).
• Recruitment materials include a flyer (K2_Recruitment_Material_Flyer) and letters to patient associations (K2_Recruitment_Material_Letter_Patient_Associations).
• If insufficient Group 2 subjects, controls will be recruited from existing cohorts Lifelines or PARASOL (registry/cohort-based recruitment).

Netherlands

Earliest CTIS Part Ii Submission Date

09-12-2024

Latest Decision Or Authorization Date

22-09-2025

Processing Time Days

287

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"ZonMW","duties_or_roles":"Monetary support","organisation_type":""}