From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19

Sponsor
University Medical Center Groningen
Study ID
NCT06911476
Status
Not Yet Recruiting

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Conditions

  • FAP
  • FAPI
  • Fibroblast
  • Fibroblast Activation Protein Inhibitor
  • Long COVID
  • Long Covid-19
  • PASC
  • PASC Post Acute Sequelae of COVID 19
  • Restrictive Lung Disease

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Study Details

Rationale: The diagnosis and pathogenesis of long COVID remains unknown. We have previously shown that \[68Ga\]FAPI Positron Emission Tomography-Computed Tomography (PET/CT) imaging shows potential for diagnosis and molecular understanding of this syndrome. We have previously shown that fibroblast activation protein (FAP) can be imaged in the lung, muscle and nasopharynx of long COVID patients (with dyspnea and fatigue). However, these preliminary data are derived from a selective group of patients with long COVID after critical COVID-19. We aim to explore the generalizability of these findings in patients with long COVID with dyspnea and fatigue, irrespective of the severity of their acute SARS-CoV-2 infection. Primary objective: To assess if pulmonary fibroblast activity, measured by \[68Ga\]FAPI-46 PET/CT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints. Study design: This is a ZonMw funded single centre prospective observational cohort study of long COVID-19 patients with dyspnea and fatigue. Study population: We will recruit 60 adult long COVID patients (aged \>20 years) of which 30 have complaints of dyspnea and fatigue and compare them to 30 patients with resolved complaints and healthy controls. Main study parameters/endpoints: The primary endpoint is FAP expression in the lung measured by \[68Ga\]FAPI-46 PET/CT. Secondary endpoints are the expression of FAP in other tissues (muscle) and the relation between FAP and inflammation and remodelling biomarkers in various biological samples (e.g. serum/nasal epithelium). Study procedures: In a single visit day the following data and samples will be collected: questionnaires, a lung function test, 6-minute walking test, blood samples, nose swabs, \[68Ga\]FAPI PET/CT scan and HRCT scan. When increased \[68Ga\]FAPI uptake is measured in the muscles a muscle biopsy will be performed as well.

Key Dates

First listed
Apr 4, 2025
Start date
May 31, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Former PASC patients
    Former PASC patients or healthy controls. Fatigue Severity Scale ≥ 4 at time of inclusion
  • Arm: PASC patients
    PASC patients with persistent dyspnea and fatigue. Fatigue Severity Scale ≤ 4 at time of \[68Ga\]FAPI PET/CT after having previously recorded score of ≥ 4 or equivalent.
  • Arm: Back-up cohort - 'healthy' controls
    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.

Primary Outcome Measure

Pulmonary FAP expression [ Time Frame: Day 1 ]

Central Contacts

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COVID-19 / long COVID trialsInfectious disease trials

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