Predictive Immune Biomarkers of COVID-19 Pathogenesis to Influence Therapeutic Management
NCT ID: NCT04668170
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
304 participants
OBSERVATIONAL
2020-05-05
2023-05-02
Brief Summary
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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.
Detailed Description
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Secondary objectives are:
* To assess the early dynamics of SARS-CoV-2-specific cellular immunity in patients followed longitudinally
* To assess the dynamics of gd T cells during COVID-19
* Transcriptomic analysis of discrete and functionally major T cell populations
* To assess SARS-CoV-2-specific humoral immunity in patients upon recovery
Identification of early predictive biomarkers of worsening of COVID-19 patients is of paramount importance. This goal is expected to be achieved through the fine analysis of circulating immune effectors, and their dynamics, in categories of patients with very different clinical outcomes.
To date, management of clinical worsening relies mainly on supportive care in ICU, leading to prolonged stay and saturation of facilities. Earlier therapeutic intervention based on identification of robust predictive biomarkers should:
* Help physicians to take therapeutic decisions
* Improve prognosis of patients that suffered from clinical worsening
* Prevent clinical worsening and transfer to ICU
* Improve the burden relying on ICU facilities in a setting of overflow
* Improve the prevention and management of COVID-19 patients to be able to face in a near future several other waves of COVID-19 Furthermore, identification of immune effectors implicated in tissular damages may also help to identify new therapeutic targets.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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hospitalized patients
very well-defined population of COVID-19 patients with the following outcomes:
Patients with severe disease requiring on admission ICU management for SARS, Non-severe hospitalized patients with secondary clinical worsening requiring ICU management, Non-severe hospitalized patients without clinical worsening requiring ICU management.
Blood collection on admission and longitudinally
Samples already collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
healthcare workers
mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited
Blood collection on their first consultation and 10 to 14 days later
Samples already collected on consultation (D0) and 14 days later
Interventions
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Blood collection on admission and longitudinally
Samples already collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
Blood collection on their first consultation and 10 to 14 days later
Samples already collected on consultation (D0) and 14 days later
Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in another interventional clinical study involving exploratory treatment or blood sampling.
18 Years
110 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Pierre DELOBEL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Bordeaux
Bordeau, , France
University Hospital Toulouse
Toulouse, , France
Countries
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Other Identifiers
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RC31/20/0187
Identifier Type: -
Identifier Source: org_study_id