Clincosm LogoSign in Get a demo

Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT04476602
Collaborator
(none)
182
Enrollment
1
Location
5.6
Actual Duration (Months)
32.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    182 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol
    Actual Study Start Date :
    Apr 27, 2020
    Actual Primary Completion Date :
    Oct 15, 2020
    Actual Study Completion Date :
    Oct 15, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    COVID-19 (SARS-CoV-2) patients

    adults 18 or older, ambulatory , with COVID-19 (SARS-CoV-2)

    Outcome Measures

    Primary Outcome Measures

    1. Hospital Admission [30 days]

      admission to hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • COVID-19 (SARS-CoV-2) infection Ambulatory
    Exclusion Criteria:
    • Need for hospital admission

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 410 Lakeville Road, Suite 107 New Hyde Park New York United States 11042

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Gita Lisker, MD, Northwell Health
    • Study Director: ramona ramdeo, Northwell Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gita Lisker, Physician, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT04476602
    Other Study ID Numbers:
    • 20-0618
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gita Lisker, Physician, Northwell Health
    COVID-19 (SARS-CoV-2)
    Homecare
    Ambulatory
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 14, 2022