Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Long COVID | Experimental |
| |
| COVID-19 recovered patients (Control) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample (at inclusion and 6 months later) | Biological | (56ml of blood, 8 tubes) 3 heparin, 1 EDTA , 2 SST, 2 CPT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 months |
Not provided
A/ Inclusion Criteria:
For all patients:
For patient with Long COVID :
For COVID-19 recovered patient (Control) :
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vincent DUBEE, MD, PhD | University Hospital, Angers | Principal Investigator |
| Valérie DUBUS, MD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Angers | 49933 | France |
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.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Not provided
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Two groups:
Each patient with Long COVID is paired with a matched control, based on age, sex, and date of COVID-19.
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. |
| 18 months |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |