Characterization of the Immunometabolic Signature in Long COVID-19.

NCT05758480 | Completed DMC

• 1 other identifier: 49RC22_0393
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).

Conditions

Long COVID

Keywords

Long COVID; immunometabolic; immunometabolic signatures

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Changes in immuno-metabolic signatures 6 months after the initial assessment

  18 months

• Proportion of patients with clinical improvement (return to normal life) at 6 months with correction of the immuno-metabolic signature

  18 months

Study Arms (2)

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)

Interventions

Blood sample (at inclusion and 6 months later) BIOLOGICAL

(56ml of blood, 8 tubes) 3 heparin, 1 EDTA , 2 SST, 2 CPT

COVID-19 recovered patients (Control); Patients with Long COVID

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.

COVID-19 recovered patients (Control); Patients with Long COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all patients:
• Age \> 18 years
• Symptomatic COVID-19 diagnosed after 01JAN2021, confirmed by RT-PCR or Antigen test
• Patient covered by the French health insurance
• Signature of the informed consent
• For patient with Long COVID :
• 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) :
• Return to Usual Health after SARS-CoV-2 infection (patient declaration)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vincent DUBEE, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Valérie DUBUS, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 7, 2023
• Study Start: May 24, 2023
• Primary Completion: May 7, 2025
• Study Completion: November 3, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
• Access Criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

Locations

FR (1)