PASC Post Acute Sequelae of COVID 19LIBERATENCT06911476
From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19
An observational study of PASC Post Acute Sequelae of COVID 19 and Long COVID, run by University Medical Center Groningen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- PASC Post Acute Sequelae of COVID 19, Long COVID, Long Covid-19
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from the P4O2 COVID-19 cohort (The Netherlands - www.p4o2.org). If too few patients from the P4O2 cohort are willing or eligible to participate in the LIBERATE study, 'healthy' controls from other cohorts may be included as a third control group to meet the required number of participants.
Who may be able to join
- 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.
Who cannot join
- Inability or unwilling to give informed consent.
- History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
- Individuals who are pregnant or currently breastfeeding are not eligible to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: From Inflammation Biomarkers to Remoddeling (FAPI PET/CT) Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19
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.
Read more
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.
- Conditions
- PASC Post Acute Sequelae of COVID 19, Long COVID, Long Covid-19, PASC, FAPI, FAP
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Former PASC patients | Former PASC patients or healthy controls. Fatigue Severity Scale ≥ 4 at time of inclusion | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary FAP expression
To compare pulmonary FAP expression between patients with persistent PASC and patients recovered from PASC. Pulmonary FAP expression will be measured via the pulmonary FAPI uptake on the [68Ga]FAPI-46 PET/CT scan. Uptake is measured as whole lung SULmean (standardized uptake value corrected for lean body mass) corrected for the background signal (bloodpool). Resulting in the target-to-background ratio (TBR) of the whole lung.
Measured: Day 1
Secondary outcomes (4)
Whole body FAP expression
To compare whole body FAPI uptake in patients with persistent PASC vs patients recovered from PASC. Whole body FAPI uptake is measured in the muscle via automated segmentation. Mean muscle uptake values are calculated.
Measured: Day 1
Pulmonary FAP expression vs clinical endpoints
To compare pulmonary FAPI uptake (expressed as the mean of the whole lung) to clinical endpoints (e.g. lung function, 6-minute walking test (6-MWT) and self-reported daily impairments assessed by several questionnaires).
Measured: Day 1
Whole body FAP expression vs clinical endpoints
To compare whole body FAPI uptake (expressed as the mean of the whole lung) to clinical endpoints (e.g. 6-minute walking test (6-MWT) and self-reported daily impairments assessed by several questionnaires).
Measured: Day 1
Serum biomarkers
To explorer serum biomarkers (e.g. soluble FAP and cytokines/growthfactors) and cellular phenotypes of inlammation and remodelling in relation to FAPI uptake (expressed as TBRmean of the whole lung).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PASC Post Acute Sequelae of COVID 19Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Pillay, MD PhD, Principal investigator, Department of Intensive Care, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911476
- Sponsor's protocol ID
- 19097
- Other IDs
- ZonMW, 2024-511294-29-00
- Acronym
- LIBERATE
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Inflammation Biomarkers to Remoddeling (FAPI PET/CT) Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19
- ClinicalTrials.gov ID
- NCT06911476
- Acronym / sponsor ID
- LIBERATE / 19097
- Conditions
- PASC Post Acute Sequelae of COVID 19, Long COVID, Long Covid-19, PASC, FAPI, FAP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Former PASC patients | – | –Former PASC patients or healthy controls. Fatigue Severity Scale ≥ 4 at time of inclusion |
| 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the P4O2 COVID-19 cohort (The Netherlands - www.p4o2.org). If too few patients from the P4O2 cohort are willing or eligible to participate in the LIBERATE study, 'healthy' controls from other cohorts may be included as a third control group to meet the required number of participants.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability or unwilling to give informed consent.
- History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
- Individuals who are pregnant or currently breastfeeding are not eligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary FAP expression
Time frame: Day 1
To compare pulmonary FAP expression between patients with persistent PASC and patients recovered from PASC. Pulmonary FAP expression will be measured via the pulmonary FAPI uptake on the [68Ga]FAPI-46 PET/CT scan. Uptake is measured as whole lung SULmean (standardized uptake value corrected for lean body mass) corrected for the background signal (bloodpool). Resulting in the target-to-background ratio (TBR) of the whole lung.
4 secondary outcomes
Whole body FAP expression
Time frame: Day 1
Pulmonary FAP expression vs clinical endpoints
Time frame: Day 1
Whole body FAP expression vs clinical endpoints
Time frame: Day 1
Serum biomarkers
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided. Data will be made available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J Pillay, MD PhD principal investigator
Department of Intensive Care, University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of PASC Post Acute Sequelae of COVID 19 and Long COVID, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Desk UMCG - LIBERATE (+31652724087, LIBERATE@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary FAP expression (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.