BIOCOVID: Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Recruiting
CT.gov ID
NCT04485364
Collaborator
Versailles Hospital (Other), Centre Hospitalier Victor Dupouy (Other)
100
1
32.6
3.1

Study Details

Study Description

Brief Summary

The research is a prospective, multicentric (Groupe hospitalier Paris Saint-Joseph, Centre Hospitalier de Versailles André Mignot and Centre Hospitalier Victor Dupouy), non-interventional, prospective study. It aims at measuring eicosanoids at different stages of Covid-19 infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The reason for the involvement of overweight in the severity of viral respiratory pathologies, particularly during influenza and coronavirus infections, has been the subject of numerous studies which have made it possible to objectify the importance of viral load (at least in mice), particularly in the lower airways and in the alveolar sacs, leading to tissue alteration and alveolar haemorrhage. The mechanisms responsible for alveolar damage during viral pathologies, particularly Coronavirus, are very similar to those observed during acute respiratory distress syndromes in adults. In many situations, endotoxin (or lipopolysaccharide, LPS) plays a major role in the pathophysiology and even the severity of respiratory damage, in particular due to the existence of circulating endotoxin from the causative pathogen (Gram-negative bacteria), but also due to translocation of digestive origin in the context of sepsis (systemic inflammatory response) which is associated with (if not responsible for) respiratory aggression. The importance of this mechanism during pulmonary aggression of viral origin is however unknown. This respiratory attack is associated with a major systemic inflammatory response, reported during the course of Covid-19 infection as corresponding to a "cytokine storm". However, the course of the inflammation is poorly understood and its prognostic nature in the occurrence of a secondarily severe form is not yet better illustrated.

    The inflammatory reaction (cytokines, eicosanoids, etc.) is an essential process for the elimination of pathogens by the host, but it must be limited in intensity and duration, otherwise it becomes deleterious for the infected organ. In the case of the lungs, it can induce an acute respiratory distress syndrome (ARDS), which can be severe as in Covid-19 patients with complications. It can be hypothesized that in the early stages of infection, these mediators may play a protective role against Covid-19. Inhibition of these mediators may therefore be deleterious as has been observed in subjects who have taken non-steroidal anti-inflammatory drugs (NSAIDs) that inhibit the production of eicosanoids.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study
    Actual Study Start Date :
    Apr 14, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory response in the evolution of respiratory diseases [6 months = the study duration]

      The importance of the inflammatory response in the evolution of respiratory disease during the the patients' hospital care based on criteria such as: The search for systemic biomarkers: the previous work led by the Saint Joseph Hospital Group team has highlighted the potential interest of biomarkers of inflammation in the diagnosis of infectious pathology as well as in the eventual prognosis of these patients. and the study of the production of eicosanoids and their presence in the systemic circulation and in the respiratory tree.

    Secondary Outcome Measures

    1. Impact of the respiratory disease during mechanical ventilation [6 months = the study duration]

      Evolution of respiratory pathology during mechanical ventilation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient aged over 18 years

    • French-speaking

    • Patient whose Covid-19 respiratory infection was confirmed by laboratory tests, PCR and any other commercial or public health tests

    • Patient hospitalized in intensive care unit and under invasive mechanical ventilation for less than three days (early inflammatory phase)

    • Adult acute respiratory distress syndrome according to the Berlin definition

    • Patient on long-term statin therapy regardless of the rationale for treatment (or without treatment for the control group).

    Exclusion Criteria:
    • Patient/family or "medical" proxy who refuses the patient's participation in the study

    • Patient under guardianship or curatorship

    • Patient deprived of liberty

    • Patient under the safeguard of justice.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph
    • Versailles Hospital
    • Centre Hospitalier Victor Dupouy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04485364
    Other Study ID Numbers:
    • BIOCOVID
    First Posted:
    Jul 24, 2020
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Groupe Hospitalier Paris Saint Joseph
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 31, 2022