<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/NCT04452942</url>
  </required_header>
  <id_info>
    <org_study_id>EC1153-2-01</org_study_id>
    <nct_id>NCT04452942</nct_id>
  </id_info>
  <brief_title>Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)</brief_title>
  <official_title>Dynamic Changes in Cytokine and Eicosanoid Mediators Among Hospitalized Patients With Coronavirus Infectious Disease 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EicOsis Human Health Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EicOsis Human Health Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, single center, observational, cohort study of patients to (1)&#xD;
      describe the kinetics and temporal relationship of changes in eicosanoid and cytokine&#xD;
      mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the&#xD;
      dynamic changes in eicosanoid mediators with available patient clinical status, including&#xD;
      measures of severity of illness, routine laboratory tests, and outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes on eicosanoid lipid mediators</measure>
    <time_frame>10 days</time_frame>
    <description>Temporal changes on eicosanoid lipid mediators over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes on plasma levels of a panel of 40 human cytokines and chemokines</measure>
    <time_frame>10 days</time_frame>
    <description>Temporal changes on the levels of 40 human cytokines, chemokines and growth factors included in a commercially available panel (Bio-Rad, Human Chemokine Panel, 40-Plex #171AK99MR2) over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe clinical outcome</measure>
    <time_frame>Through study completion, an average of 10 days</time_frame>
    <description>Severe clinical outcome defined as need for ICU admission and/or need for mechanical ventilation and/or multi-organ failure and/or death during hospitalization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with laboratory-confirmed SARS-CoV-2 infection requiring hospitalization for&#xD;
        COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Admitted to a hospital with symptoms suggestive of COVID-19.&#xD;
&#xD;
          2. Confirmed infection with SARS-CoV-2 as determined by polymerase chain reaction (PCR)&#xD;
             or other commercial or public health assay in the 72 hours prior to hospital admission&#xD;
             or any time during hospital admission.&#xD;
&#xD;
          3. Subject (or legally authorized representative) provides written informed consent prior&#xD;
             to initiation of any study procedures.&#xD;
&#xD;
          4. Understands and agrees to comply with planned study procedures.&#xD;
&#xD;
          5. Agrees to the collection of whole blood samples.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to obtain informed consent.&#xD;
&#xD;
          2. Anticipated transfer to another hospital which is not a study site within 48 hours.&#xD;
&#xD;
          3. Inability to obtain sequential blood samples due to patient's characteristics (i.e.&#xD;
             difficult vascular access).&#xD;
&#xD;
          4. Obstetric patients.&#xD;
&#xD;
          5. Prisoners.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Irene Cortes-Puch, MD</last_name>
    <phone>3018215857</phone>
    <email>icortespuch@eicosis.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Ana Mavarez-Martinez, MD</last_name>
      <email>ana.mavarezmartinez@stonybrookmedicine.edu</email>
    </contact>
    <investigator>
      <last_name>Sergio Bergese, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.eicosis.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus Disease 2019</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Eicosanoids</keyword>
  <keyword>Eicosanoid storm</keyword>
  <keyword>Cytokine storm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04452942
org study id: EC1153-2-01
nct id: NCT04452942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, single center, observational, cohort study of patients to (1)
      describe the kinetics and temporal relationship of changes in eicosanoid and cytokine
      mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the
      dynamic changes in eicosanoid mediators with available patient clinical status, including
      measures of severity of illness, routine laboratory tests, and outcomes.
observational model: Cohort
time perspective: Prospective
measure: Changes on eicosanoid lipid mediators
time frame: 10 days
description: Temporal changes on eicosanoid lipid mediators over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization
measure: Changes on plasma levels of a panel of 40 human cytokines and chemokines
time frame: 10 days
description: Temporal changes on the levels of 40 human cytokines, chemokines and growth factors included in a commercially available panel (Bio-Rad, Human Chemokine Panel, 40-Plex #171AK99MR2) over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization.
measure: Severe clinical outcome
time frame: Through study completion, an average of 10 days
description: Severe clinical outcome defined as need for ICU admission and/or need for mechanical ventilation and/or multi-organ failure and/or death during hospitalization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Irene Cortes-Puch, MD
phone: 3018215857
email: icortespuch@eicosis.com
facility: 
contact: 
investigator: 
country: United States
url: http://www.eicosis.com
description: Related Info
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No