Characterization of the Immunometabolic Signature in Long COVID-19.

Long COVID Clinical Trial

— LoCo-ImMet  

Official title:

Characterization of the Immunometabolic Signature in Long COVID-19.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758480
• Other study ID #: LoCo-ImMet
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Angers
• Contact: Vincent DUBEE, MD, PhD
• Phone: 0033241353279
• Email: vincent.dubee[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

Biological:
• Blood sample (at inclusion and 6 months later)
(56ml of blood, 8 tubes) 3 heparin, 1 EDTA , 2 SST, 2 CPT

Other:
• 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.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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