Long COVIDLoCo-ImMetNCT05758480
Characterization of the Immunometabolic Signature in Long COVID-19.
A study testing Blood sample (at inclusion and 6 months later) and Patient questionnaires (at inclusion and 6 months later) in people with Long COVID, run by University Hospital, Angers at 1 site in France.
Trial summary
The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- What is being tested?
- Blood sample (at inclusion and 6 months later) and Patient questionnaires (at inclusion and 6 months later)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2023to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
A/ Inclusion Criteria:
- For all patients:
- Age > 18 years
- Symptomatic COVID-19 diagnosed after 01JAN2021, confirmed by RT-PCR or Antigen test
- Last SARS-CoV-2 infection diagnosed more than 12 weeks before inclusion
- Patient covered by the French health insurance
- Signature of the informed consent
- For patient with Long COVID :
- At least one of the following symptoms during the week preceding inclusion: abnormal fatigue, dyspnoea sine materia, abnormal pain (chest, joint, muscle, headache), unusual neurocognitive disorders (concentration disorders, "brain fog", language/memory disorders, paraesthesia)
- Absence of Return to Usual Health after SARS-CoV-2 infection (patient declaration)
- Absence of alternative diagnosis for the symptoms
- For COVID-19 recovered patient (Control) :
- None of the following symptoms in the 3 week before inclusion: abnormal fatigue, dyspnoea sine materia, abnormal pain (chest, joint, muscle, headache), unusual neurocognitive disorders (concentration disorders, "brain fog", language/memory disorders, paraesthesia)
- Return to Usual Health after SARS-CoV-2 infection (patient declaration)
B/ Exclusion Criteria:
- History of severe COVID-19 (Hospitalization)
- Symptoms caused by sequelae of SARS-CoV-2 infection (in particular, persistence of lung parenchymal abnormalities : pulmonary fibrosis, persistent alveolitis on CT-Scan)
- Significant Depression or anxiety symptoms, as assessed by a > 10 score on the A or D items of the Hospital anxiety and depression scale (HAD)
- Presence of one of the following diseases:
- Inborn errors of metabolism
- estimated Glomerular filtration rate < 30 ml/min (MDRD)
- Autoimmune disease
- Immunosuppressive treatment or immune deficiency
- Symptomatic heart failure
- Respiratory failure (COPD stage ≥ 3 or oxygen therapy)
- Solid cancer or active blood disease
- Severe malnutrition (albumin < 30 g/L or weight loss ≥10% in 6 months)
- Obesity with BMI ≥ 35 kg/m²
- Diabetes not controlled by diet alone
- Pregnant, breastfeeding or parturient women
- Deprivation of liberty by judicial or administrative decision
- Mandatory Psychiatric Care
- Protected by decision of law
- Unable to express consent
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).
Read the detailed description
The mechanisms underlying Long COVID remain poorly understood. Among the symptoms most frequently reported by patients with long COVID, some (fatigue, neurocognitive disorders, muscular weakness) are similar to those reported by patients with innate or acquired abnormalities in energy metabolism, suggesting that metabolic changes could play a role in the disease. On the other hand, other studies have shown that COVID-19 induces an immune dysregulation that could persist after recovery.
The hypothesis of this study is that there are subtle but detectable immunometabolic changes in plasma and PBMC of patients with long COVID. The identification of these specific signatures would help to better understand the physiopathology of this disease and to identify possible therapeutic strategies .
The primary objective of this study is to identify immunometabolic signatures in plasma and peripheral blood mononuclear cells (PBMC) of patients with long COVID, as compared to patients who recovered from COVID-19 without prolonged symptoms.
- Conditions
- Long COVID
- Being tested
- Blood sample (at inclusion and 6 months later), Patient questionnaires (at inclusion and 6 months later)
- Keywords
- Long COVID, immunometabolic, immunometabolic signatures
- 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.
Blood sample (at inclusion and 6 months later)Biological
(56ml of blood, 8 tubes) 3 heparin, 1 EDTA , 2 SST, 2 CPT
Patient questionnaires (at inclusion and 6 months later)Other
(4 questionnaires) Symptoms in the last week, Fatigue Impact Scale (FIS), Short-Form 36 (SF-36) and Nijmegen.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Long COVID | Experimental | Not described Receives: Biological: Blood sample (at inclusion and 6 months later); Other: Patient questionnaires (at inclusion and 6 months later) |
| COVID-19 recovered patients (Control) | Active comparator | Not described Receives: Biological: Blood sample (at inclusion and 6 months later); Other: Patient questionnaires (at inclusion and 6 months later) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of immunometabolic signatures specific of Long COVID in the plasma and mononuclear cells
Statistical analyzes (multivariate) by Orthogonal Projections to Latent Structures Discriminant Analysis (OPLS-DA) (Q2Ycum > 0.5, P-value (CV-ANOVA) ≤0.05, Q2Ycum, test permutations <0) or the median (AUROC test sets) ≥ 0.8 and the median of the p-values associated with the AUROCs of the test sets ≤ 0.05 in the plasma and/or the PBMCs.
Measured: 18 months
Concentration of metabolites and immune mediators in the plasma and mononuclear cells
Comparison of metabolites and immune mediators in the blood and PBMC of patients with long COVID will be compared with those of control patients using statistical tests after correction of the alpha risk.
Measured: 18 months
Secondary outcomes (2)
Changes in immuno-metabolic signatures 6 months after the initial assessment
Significant changes in concentration of metabolites and immune mediators 6 month after inclusion, in comparison with the initial assessment, will be identifed using paired statistical tests with correction of the alpha risk
Measured: 18 months
Proportion of patients with clinical improvement (return to normal life) at 6 months with correction of the immuno-metabolic signature
The correlation between clinical signs of long COVID and the immuno-metabolic signature specific of long COVID identified in the study will be assessed 6 months after inclusion.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start24 May 2023
- Primary completion7 May 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: 1. Patients with Long COVID 2. Control group composed of patients who recovered from COVID-19 without persistent symptoms. Each patient with Long COVID is paired with a matched control, based on age, sex, and date of COVID-19.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vincent DUBEE, MD, PhD, Principal investigator, University Hospital, AngersValérie DUBUS, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758480
- Sponsor's protocol ID
- 49RC22_0393
- Acronym
- LoCo-ImMet
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Immunometabolic Signature in Long COVID-19.
- ClinicalTrials.gov ID
- NCT05758480
- Acronym / sponsor ID
- LoCo-ImMet / 49RC22_0393
- Conditions
- Long COVID
- Keywords
- Long COVID, immunometabolic, immunometabolic signatures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 24 May 2023 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 7 Mar 2023 (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.
The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).
Detailed description
The mechanisms underlying Long COVID remain poorly understood. Among the symptoms most frequently reported by patients with long COVID, some (fatigue, neurocognitive disorders, muscular weakness) are similar to those reported by patients with innate or acquired abnormalities in energy metabolism, suggesting that metabolic changes could play a role in the disease. On the other hand, other studies have shown that COVID-19 induces an immune dysregulation that could persist after recovery.
The hypothesis of this study is that there are subtle but detectable immunometabolic changes in plasma and PBMC of patients with long COVID. The identification of these specific signatures would help to better understand the physiopathology of this disease and to identify possible therapeutic strategies .
The primary objective of this study is to identify immunometabolic signatures in plasma and peripheral blood mononuclear cells (PBMC) of patients with long COVID, as compared to patients who recovered from COVID-19 without prolonged symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: 1. Patients with Long COVID 2. Control group composed of patients who recovered from COVID-19 without persistent symptoms. Each patient with Long COVID is paired with a matched control, based on age, sex, and date of COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Patients with Long COVID | Experimental | Biological: Blood sample (at inclusion and 6 months later), Other: Patient questionnaires (at inclusion and 6 months later) |
| COVID-19 recovered patients (Control) | Active comparator | Biological: Blood sample (at inclusion and 6 months later), Other: Patient questionnaires (at inclusion and 6 months later) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample (at inclusion and 6 months later)(56ml of blood, 8 tubes) 3 heparin, 1 EDTA , 2 SST, 2 CPT | Biological | COVID-19 recovered patients (Control), Patients with Long COVID |
| Patient questionnaires (at inclusion and 6 months later)(4 questionnaires) Symptoms in the last week, Fatigue Impact Scale (FIS), Short-Form 36 (SF-36) and Nijmegen. | Other | COVID-19 recovered patients (Control), Patients with Long COVID |
Primary outcome
Presence of immunometabolic signatures specific of Long COVID in the plasma and mononuclear cells
Time frame: 18 months
Statistical analyzes (multivariate) by Orthogonal Projections to Latent Structures Discriminant Analysis (OPLS-DA) (Q2Ycum > 0.5, P-value (CV-ANOVA) ≤0.05, Q2Ycum, test permutations <0) or the median (AUROC test sets) ≥ 0.8 and the median of the p-values associated with the AUROCs of the test sets ≤ 0.05 in the plasma and/or the PBMCs.
Concentration of metabolites and immune mediators in the plasma and mononuclear cells
Time frame: 18 months
Comparison of metabolites and immune mediators in the blood and PBMC of patients with long COVID will be compared with those of control patients using statistical tests after correction of the alpha risk.
2 secondary outcomes
Changes in immuno-metabolic signatures 6 months after the initial assessment
Time frame: 18 months
Proportion of patients with clinical improvement (return to normal life) at 6 months with correction of the immuno-metabolic signature
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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. This study is not recruiting at the moment.
Vincent DUBEE, MD, PhD principal investigator
University Hospital, Angers
Valérie DUBUS, MD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample (at inclusion and 6 months later) and Patient questionnaires (at inclusion and 6 months later) in people with Long COVID, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of immunometabolic signatures specific of Long COVID in the plasma and mononuclear cells (time frame: 18 months). The study lists 2 primary outcomes in all. 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 20 Jul 2026.