<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04485364</url>
  </required_header>
  <id_info>
    <org_study_id>BIOCOVID</org_study_id>
    <nct_id>NCT04485364</nct_id>
  </id_info>
  <brief_title>Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia</brief_title>
  <acronym>BIOCOVID</acronym>
  <official_title>Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Victor Dupouy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <brief_summary>
    <textblock>
      The research is a prospective, multicentric (Groupe hospitalier Paris Saint-Joseph, Centre&#xD;
      Hospitalier de Versailles André Mignot and Centre Hospitalier Victor Dupouy),&#xD;
      non-interventional, prospective study. It aims at measuring eicosanoids at different stages&#xD;
      of Covid-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The reason for the involvement of overweight in the severity of viral respiratory&#xD;
      pathologies, particularly during influenza and coronavirus infections, has been the subject&#xD;
      of numerous studies which have made it possible to objectify the importance of viral load (at&#xD;
      least in mice), particularly in the lower airways and in the alveolar sacs, leading to tissue&#xD;
      alteration and alveolar haemorrhage. The mechanisms responsible for alveolar damage during&#xD;
      viral pathologies, particularly Coronavirus, are very similar to those observed during acute&#xD;
      respiratory distress syndromes in adults. In many situations, endotoxin (or&#xD;
      lipopolysaccharide, LPS) plays a major role in the pathophysiology and even the severity of&#xD;
      respiratory damage, in particular due to the existence of circulating endotoxin from the&#xD;
      causative pathogen (Gram-negative bacteria), but also due to translocation of digestive&#xD;
      origin in the context of sepsis (systemic inflammatory response) which is associated with (if&#xD;
      not responsible for) respiratory aggression. The importance of this mechanism during&#xD;
      pulmonary aggression of viral origin is however unknown. This respiratory attack is&#xD;
      associated with a major systemic inflammatory response, reported during the course of&#xD;
      Covid-19 infection as corresponding to a &quot;cytokine storm&quot;. However, the course of the&#xD;
      inflammation is poorly understood and its prognostic nature in the occurrence of a&#xD;
      secondarily severe form is not yet better illustrated.&#xD;
&#xD;
      The inflammatory reaction (cytokines, eicosanoids, etc.) is an essential process for the&#xD;
      elimination of pathogens by the host, but it must be limited in intensity and duration,&#xD;
      otherwise it becomes deleterious for the infected organ. In the case of the lungs, it can&#xD;
      induce an acute respiratory distress syndrome (ARDS), which can be severe as in Covid-19&#xD;
      patients with complications. It can be hypothesized that in the early stages of infection,&#xD;
      these mediators may play a protective role against Covid-19. Inhibition of these mediators&#xD;
      may therefore be deleterious as has been observed in subjects who have taken non-steroidal&#xD;
      anti-inflammatory drugs (NSAIDs) that inhibit the production of eicosanoids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2020</start_date>
  <completion_date type="Actual">June 6, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammatory response in the evolution of respiratory diseases</measure>
    <time_frame>6 months = the study duration</time_frame>
    <description>The importance of the inflammatory response in the evolution of respiratory disease during the the patients' hospital care based on criteria such as:&#xD;
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.&#xD;
and the study of the production of eicosanoids and their presence in the systemic circulation and in the respiratory tree.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of the respiratory disease during mechanical ventilation</measure>
    <time_frame>6 months = the study duration</time_frame>
    <description>Evolution of respiratory pathology during mechanical ventilation.</description>
  </secondary_outcome>
  <enrollment type="Actual">97</enrollment>
  <condition>Coronavirus</condition>
  <condition>Covid19</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During the patient's hospitalization, a blood sample will be taken on a citrate tube in&#xD;
      addition to the usual samples during the patient's hospital care. A tracheal aspiration will&#xD;
      be systematically performed in order to limit patient congestion and the risk of atelectasis.&#xD;
&#xD;
      These samples will be destroyed after the study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient aged over 18 years old who was positively tested to the Covid 19 infection and has&#xD;
        been hospitalized in the Intensive care Unit and under invasive mechanical ventilation for&#xD;
        less than 3 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged over 18 years&#xD;
&#xD;
          -  French-speaking&#xD;
&#xD;
          -  Patient whose Covid-19 respiratory infection was confirmed by laboratory tests, PCR&#xD;
             and any other commercial or public health tests&#xD;
&#xD;
          -  Patient hospitalized in intensive care unit and under invasive mechanical ventilation&#xD;
             for less than three days (early inflammatory phase)&#xD;
&#xD;
          -  Adult acute respiratory distress syndrome according to the Berlin definition&#xD;
&#xD;
          -  Patient on long-term statin therapy regardless of the rationale for treatment (or&#xD;
             without treatment for the control group).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient/family or &quot;medical&quot; proxy who refuses the patient's participation in the study&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient under the safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Bradley BT, Bryan A. Emerging respiratory infections: The infectious disease pathology of SARS, MERS, pandemic influenza, and Legionella. Semin Diagn Pathol. 2019 May;36(3):152-159. doi: 10.1053/j.semdp.2019.04.006. Epub 2019 Apr 17.</citation>
    <PMID>31054790</PMID>
  </results_reference>
  <results_reference>
    <citation>Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20.</citation>
    <PMID>29052924</PMID>
  </results_reference>
  <results_reference>
    <citation>Vijayanand P, Wilkins E, Woodhead M. Severe acute respiratory syndrome (SARS): a review. Clin Med (Lond). 2004 Mar-Apr;4(2):152-60. doi: 10.7861/clinmedicine.4-2-152.</citation>
    <PMID>15139736</PMID>
  </results_reference>
  <results_reference>
    <citation>Fehr AR, Channappanavar R, Perlman S. Middle East Respiratory Syndrome: Emergence of a Pathogenic Human Coronavirus. Annu Rev Med. 2017 Jan 14;68:387-399. doi: 10.1146/annurev-med-051215-031152. Epub 2016 Aug 26.</citation>
    <PMID>27576010</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eicosanoids</keyword>
  <keyword>biomarkers</keyword>
  <keyword>covid19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04485364
org study id: BIOCOVID
nct id: NCT04485364
lead sponsor: 
collaborator: 
collaborator: 
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.
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.
observational model: Other
time perspective: Prospective
measure: Inflammatory response in the evolution of respiratory diseases
time frame: 6 months = the study duration
description: 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.
measure: Impact of the respiratory disease during mechanical ventilation
time frame: 6 months = the study duration
description: Evolution of respiratory pathology during mechanical ventilation.
During the patient's hospitalization, a blood sample will be taken on a citrate tube in
      addition to the usual samples during the patient's hospital care. A tracheal aspiration will
      be systematically performed in order to limit patient congestion and the risk of atelectasis.

      These samples will be destroyed after the study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Bradley BT, Bryan A. Emerging respiratory infections: The infectious disease pathology of SARS, MERS, pandemic influenza, and Legionella. Semin Diagn Pathol. 2019 May;36(3):152-159. doi: 10.1053/j.semdp.2019.04.006. Epub 2019 Apr 17.
PMID: 31054790
citation: Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20.
PMID: 29052924
citation: Vijayanand P, Wilkins E, Woodhead M. Severe acute respiratory syndrome (SARS): a review. Clin Med (Lond). 2004 Mar-Apr;4(2):152-60. doi: 10.7861/clinmedicine.4-2-152.
PMID: 15139736
citation: Fehr AR, Channappanavar R, Perlman S. Middle East Respiratory Syndrome: Emergence of a Pathogenic Human Coronavirus. Annu Rev Med. 2017 Jan 14;68:387-399. doi: 10.1146/annurev-med-051215-031152. Epub 2016 Aug 26.
PMID: 27576010
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia