<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/NCT04476602</url>
  </required_header>
  <id_info>
    <org_study_id>20-0618</org_study_id>
    <nct_id>NCT04476602</nct_id>
  </id_info>
  <brief_title>Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol</brief_title>
  <acronym>CROWN</acronym>
  <official_title>Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19&#xD;
      (SARS-CoV-2) patients with moderate to high risk features&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the peak of the COVID-19 (SARS-CoV-2) pandemic in New York City, there was a shortage of&#xD;
      hospital resources as well as a fear among many New Yorkers of going to the hospital.&#xD;
      Emergency Services dead on arrival calls increased by as much as eight-fold.We created the&#xD;
      CROWN Program, a pulmonary physician guided home-care protocol to treat ambulatory COVID-19&#xD;
      (SARS-CoV-2) patients with moderate to high risk features. This is a retrospective review of&#xD;
      our CROWN program's patient characteristics, results and outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 15, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Admission</measure>
    <time_frame>30 days</time_frame>
    <description>admission to hospital</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">182</enrollment>
  <condition>Covid-19 (SARS-CoV-2)</condition>
  <arm_group>
    <arm_group_label>COVID-19 (SARS-CoV-2) patients</arm_group_label>
    <description>adults 18 or older, ambulatory , with COVID-19 (SARS-CoV-2)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        General public&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 (SARS-CoV-2) infection Ambulatory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for hospital admission&#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_official>
    <last_name>Gita Lisker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ramona ramdeo</last_name>
    <role>Study Director</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>410 Lakeville Road, Suite 107</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 13, 2022</last_update_submitted>
  <last_update_submitted_qc>July 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Gita Lisker</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>COVID-19 (SARS-CoV-2)</keyword>
  <keyword>Homecare</keyword>
  <keyword>Ambulatory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04476602
org study id: 20-0618
nct id: NCT04476602
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19
      (SARS-CoV-2) patients with moderate to high risk features
At the peak of the COVID-19 (SARS-CoV-2) pandemic in New York City, there was a shortage of
      hospital resources as well as a fear among many New Yorkers of going to the hospital.
      Emergency Services dead on arrival calls increased by as much as eight-fold.We created the
      CROWN Program, a pulmonary physician guided home-care protocol to treat ambulatory COVID-19
      (SARS-CoV-2) patients with moderate to high risk features. This is a retrospective review of
      our CROWN program's patient characteristics, results and outcomes.
observational model: Cohort
time perspective: Retrospective
measure: Hospital Admission
time frame: 30 days
description: admission to hospital
arm group label: COVID-19 (SARS-CoV-2) patients
description: adults 18 or older, ambulatory , with COVID-19 (SARS-CoV-2)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gita Lisker, MD
role: Principal Investigator
affiliation: Northwell Health
last name: ramona ramdeo
role: Study Director
affiliation: Northwell Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Gita Lisker
investigator title: Physician
mesh term: COVID-19
sharing ipd: No