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NCT05758480
Characterization of the Immunometabolic Signature in Long COVID-19.
Conditions: Long COVID
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: University Hospital, Angers
Location: France
Summary
The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).
Eligibility Criteria
A/ Inclusion Criteria:For all patients:Age > 18 yearsSymptomatic COVID-19 diagnosed after 01JAN2021, confirmed by RT-PCR or Antigen testLast SARS-CoV-2 infection diagnosed more than 12 weeks before inclusionPatient covered by the French health insuranceSignature of the informed consentFor 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 symptomsFor 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 metabolismestimated Glomerular filtration rate < 30 ml/min (MDRD)Autoimmune diseaseImmunosuppressive treatment or immune deficiencySymptomatic heart failureRespiratory failure (COPD stage ≥ 3 or oxygen therapy)Solid cancer or active blood diseaseSevere malnutrition (albumin < 30 g/L or weight loss ≥10% in 6 months)Obesity with BMI ≥ 35 kg/m²Diabetes not controlled by diet alonePregnant, breastfeeding or parturient womenDeprivation of liberty by judicial or administrative decisionMandatory Psychiatric CareProtected by decision of lawUnable to express consent
Source: ClinicalTrials.gov (NCT05758480). StuddyBuddy aggregates publicly available trial information.