Clinical trial

Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management

Name
RC31/20/0187
Description
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to death. Predictive markers of clinical worsening after admission are lacking. COVID-19 immunopathogenesis and relevant therapeutic strategies are still under investigation. Although viral shedding peaks during the first week of symptoms, reports show that clinical deterioration often coincides with the development of host antiviral immune responses. The inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses that may enter the pulmonary circulation in large numbers and play an immune damaging role causing lung functional disability resulting in clinical worsening. Therapeutic strategies using corticosteroids or biotherapies targeting IL-6 may be valuable in some patients. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions. On these bases, the present project aims to unravel, using innovative integrated multimodal immunological approaches, immunologic predictive markers by finely characterizing from their admission innate and adaptive immune responses in two well described cohorts of COVID-19 patients that are being collected in Toulouse (COVID-BioToul) and Bordeaux (COLCOV-19 BX).Those two biological cohorts are connected with two clinical cohorts in Toulouse and Bordeaux in order to have a very well defined population of COVID-19 patients and their clinical outcome. In both cohorts, investigators harvest and cryopreserve biological samples, including plasma and peripheral blood mononuclear cells (PBMCs), on admission and longitudinally from patients evolving or not toward severe forms of the disease in Bordeaux and Toulouse University Hospitals and will allow to investigate primary and secondary objectives. Moreover in the two centers, there are also two clinical outpatients cohorts of healthcare workers attending dedicated clinics in the frame of their surveillance medical program, which constitute groups of patients with benign forms of COVID-19.
Trial arms
Trial start
2020-05-05
Estimated PCD
2021-12-31
Trial end
2023-05-02
Status
Completed
Treatment
Blood collection on admission and longitudinally
Samples already collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
Arms:
hospitalized patients
Blood collection on their first consultation and 10 to 14 days later
Samples already collected on consultation (D0) and 14 days later
Arms:
healthcare workers
Size
304
Primary endpoint
Immune signature on admission : phenotypic profile of blood T-cells
Day 0
Immune signature on admission : inflammatory cytokines
Day 0
Eligibility criteria
Inclusion Criteria: For COVID-19 hospitalized patients * Polymerase chain reaction (PCR) proven SARS-CoV-2 infection * Participation to Toulouse clinical cohort * Having signed consent for inclusion in the Toulouse biobanks For COVID-19 healthcare workers attending dedicated clinics * PCR proven SARS-CoV-2 infection * Having signed consent for inclusion in the Toulouse biobanks Exclusion Criteria: * Pregnancy or breastfeeding * Participation in another interventional clinical study involving exploratory treatment or blood sampling.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 304, 'type': 'ACTUAL'}}
Updated at
2023-06-22

1 organization

1 product

1 indication

Indication
COVID-19