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

July 13, 2022 updated by: Gita Lisker, Northwell Health
Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11042
        • 410 Lakeville Road, Suite 107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

General public

Description

Inclusion Criteria:

  • COVID-19 (SARS-CoV-2) infection Ambulatory

Exclusion Criteria:

  • Need for hospital admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
COVID-19 (SARS-CoV-2) patients
adults 18 or older, ambulatory , with COVID-19 (SARS-CoV-2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Admission
Time Frame: 30 days
admission to hospital
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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