<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/NCT04473131</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-05-007</org_study_id>
    <nct_id>NCT04473131</nct_id>
  </id_info>
  <brief_title>Immune Profiling of COVID19-patients Admitted to ICU</brief_title>
  <acronym>IMPROVISE</acronym>
  <official_title>Immune Profiling of COVID-19-infected Patients Admitted to the Intensive Care Unit (ICU): the IMPROVISE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Qatar University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Cornell Medical College in Qatar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hamad Medical Corporation</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>
      SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This&#xD;
      new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO,&#xD;
      the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far&#xD;
      &gt;2 million cases globally. Meanwhile, confirmed death cases reached &gt;126 thousands of&#xD;
      reported cases in 185 countries and still increasing. We anticipate that immunological&#xD;
      differences among COVID19-infected patients might be a reason behind the variation of patient&#xD;
      outcomes. Therefore, we intend to investigate cellular and humoral immune responses of&#xD;
      COVID19-positive patients, and we claim to discover new indicators of patients' prognosis.&#xD;
      Our target population includes three categories of patients staying at ICU, HMC&#xD;
      (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay,&#xD;
      multiple blood samples will be screened for leukocytes surface markers, leukocytes'&#xD;
      production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors.&#xD;
      Their plasma/serum will be used as well for immune proteomics, metabolomics, and other&#xD;
      serological tests. Such parameters can provide the more comprehensive status of&#xD;
      COVID19-infected patients at infection onset, during treatment intake, and at recovery or&#xD;
      relapse stage. Following analysis, the main prospective outcome of this study is to identify&#xD;
      the most reflective markers of COVID19-positive patients' outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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>To create an immune profile for each COVID19-positive patient during their ICU stay</measure>
    <time_frame>8 to 12 months</time_frame>
    <description>A descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To correlate patients' immune profile to disease severity and patient's outcome</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>A correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient's outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient's outcome.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COVID-19 positive</arm_group_label>
    <description>Inclusion criteria:&#xD;
Male or female aged over 18 years&#xD;
Admitted patients to ICU with a suspicious COVID19 infection&#xD;
Tested positive for SARS-CoV-2&#xD;
Exclusion criteria:&#xD;
Burn and trauma&#xD;
Any immunological diseases, or immunosuppressive medications&#xD;
Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)&#xD;
Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 negative</arm_group_label>
    <description>Inclusion criteria:&#xD;
Male or female aged over 18 years&#xD;
Admitted patients to ICU&#xD;
Tested negative for SARS-CoV-2&#xD;
Exclusion criteria:&#xD;
Burn and trauma&#xD;
Any immunological diseases, or immunosuppressive medications&#xD;
Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)&#xD;
Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heathy volunteers</arm_group_label>
    <description>Inclusion criteria:&#xD;
Male or female aged over 18 years&#xD;
Normal clinical examination&#xD;
Exclusion criteria:&#xD;
Person with an infectious syndrome during the last 90 days&#xD;
Extreme physical stress within the last week&#xD;
Person receiving within the last 90 days, a treatment based on: antivirals; antibiotics; antiparasitics; antifungals; non-steroidal anti-inflammatory drugs; immunosuppressive therapy; corticosteroids; therapeutic antibodies; chemotherapy&#xD;
Person with history of: innate or acquired immune deficiency; hematological disease; solid tumor; severe chronic disease; surgery or hospitalization within the last 2 years; pregnancy within the last year; participation to a phase I clinical assay during the last year; participation to a phase I clinical assay during the last year; pregnant or breastfeeding women; a person with restricted liberty or under legal protection&#xD;
Sample collection time points: 1 (day of blood sample donation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Only blood samples will be taken from participants for this study</description>
    <arm_group_label>COVID-19 negative</arm_group_label>
    <arm_group_label>COVID-19 positive</arm_group_label>
    <arm_group_label>Heathy volunteers</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA blood samples Yellow SST blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In this study, we are targeting to enroll two categories of patients from ICU: 100&#xD;
        COVID19-positive patients, and 100 COVID19-negative patients.&#xD;
&#xD;
        In addition to 100 healthy volunteers from the blood donation center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to ICU for suspicious COVID-19&#xD;
&#xD;
          -  Signed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immuno-compromised or immuno-deficient patients&#xD;
&#xD;
          -  Diagnosed with any immunological disorders, cancer, and onco-hematological diseases at&#xD;
             the inclusion date&#xD;
&#xD;
          -  Patients under treatment or treated within 5 years before inclusion or at the end of&#xD;
             chemotherapy within the 6 months prior to inclusion date&#xD;
&#xD;
          -  Patients under any immune-suppressive medications, antibody therapy, corticosteroids,&#xD;
             bone marrow transplant under the last 6 months of inclusion&#xD;
&#xD;
          -  Unsigned consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dr. Ali Ait Hssain</last_name>
    <phone>77172526</phone>
    <email>a_aithssain@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hamad Medical Corporation</name>
      <address>
        <city>Doha</city>
        <country>Qatar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Ait Hssain</last_name>
      <phone>44392488</phone>
      <email>a_aithssain@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ali Ait Hssain</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sara Taleb</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamad Medical Corporation</investigator_affiliation>
    <investigator_full_name>Ali Ait Hssain</investigator_full_name>
    <investigator_title>Senior consultant intensivist</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>ICU</keyword>
  <keyword>Immune profiling</keyword>
  <keyword>Humoral immunity</keyword>
  <keyword>Cellular immunity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04473131
org study id: MRC-05-007
nct id: NCT04473131
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This
      new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO,
      the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far
      >2 million cases globally. Meanwhile, confirmed death cases reached >126 thousands of
      reported cases in 185 countries and still increasing. We anticipate that immunological
      differences among COVID19-infected patients might be a reason behind the variation of patient
      outcomes. Therefore, we intend to investigate cellular and humoral immune responses of
      COVID19-positive patients, and we claim to discover new indicators of patients' prognosis.
      Our target population includes three categories of patients staying at ICU, HMC
      (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay,
      multiple blood samples will be screened for leukocytes surface markers, leukocytes'
      production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors.
      Their plasma/serum will be used as well for immune proteomics, metabolomics, and other
      serological tests. Such parameters can provide the more comprehensive status of
      COVID19-infected patients at infection onset, during treatment intake, and at recovery or
      relapse stage. Following analysis, the main prospective outcome of this study is to identify
      the most reflective markers of COVID19-positive patients' outcomes.
observational model: Cohort
time perspective: Prospective
measure: To create an immune profile for each COVID19-positive patient during their ICU stay
time frame: 8 to 12 months
description: A descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection.
measure: To correlate patients' immune profile to disease severity and patient's outcome
time frame: 4 to 6 months
description: A correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient's outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient's outcome.
arm group label: COVID-19 positive
description: Inclusion criteria:
Male or female aged over 18 years
Admitted patients to ICU with a suspicious COVID19 infection
Tested positive for SARS-CoV-2
Exclusion criteria:
Burn and trauma
Any immunological diseases, or immunosuppressive medications
Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)
Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible)
arm group label: COVID-19 negative
description: Inclusion criteria:
Male or female aged over 18 years
Admitted patients to ICU
Tested negative for SARS-CoV-2
Exclusion criteria:
Burn and trauma
Any immunological diseases, or immunosuppressive medications
Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)
Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible)
arm group label: Heathy volunteers
description: Inclusion criteria:
Male or female aged over 18 years
Normal clinical examination
Exclusion criteria:
Person with an infectious syndrome during the last 90 days
Extreme physical stress within the last week
Person receiving within the last 90 days, a treatment based on: antivirals; antibiotics; antiparasitics; antifungals; non-steroidal anti-inflammatory drugs; immunosuppressive therapy; corticosteroids; therapeutic antibodies; chemotherapy
Person with history of: innate or acquired immune deficiency; hematological disease; solid tumor; severe chronic disease; surgery or hospitalization within the last 2 years; pregnancy within the last year; participation to a phase I clinical assay during the last year; participation to a phase I clinical assay during the last year; pregnant or breastfeeding women; a person with restricted liberty or under legal protection
Sample collection time points: 1 (day of blood sample donation)
intervention type: Other
intervention name: No intervention
description: Only blood samples will be taken from participants for this study
arm group label: COVID-19 negative
arm group label: COVID-19 positive
arm group label: Heathy volunteers
EDTA blood samples Yellow SST blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Ali Ait Hssain
phone: 77172526
email: a_aithssain@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Qatar
responsible party type: Principal Investigator
investigator affiliation: Hamad Medical Corporation
investigator full name: Ali Ait Hssain
investigator title: Senior consultant intensivist
mesh term: COVID-19