Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 (STOP-COVID)

August 6, 2023 updated by: David Leaf, Brigham and Women's Hospital
Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goals of this project are to determine the independent risk factors for hospital mortality and acute organ injury, and to identify treatment strategies associated with improved survival. Additionally, we will assess outcomes according to differences in geographic and institutional parameters.

Study Type

Observational

Enrollment (Actual)

5154

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

Sampling Method

Non-Probability Sample

Study Population

Critically ill adults admitted to an intensive care unit for illness related to COVID-19

Description

Inclusion Criteria (each of the following):

  1. Adults (aged ≥18 years)
  2. Laboratory-confirmed diagnosis of COVID-19
  3. Hospitalized in the ICU for illness related to COVID-19

Exclusion Criteria:

-None

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: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-Day Mortality
Time Frame: 28-days from the day of ICU admission
28-days from the day of ICU admission

Secondary Outcome Measures

Outcome Measure
Time Frame
60-Day Mortality
Time Frame: 60-days from the day of ICU admission
60-days from the day of ICU admission
90-Day Mortality
Time Frame: 90-days from the day of ICU admission
90-days from the day of ICU admission

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

Johns Hopkins University
University of Colorado, Denver
Mayo Clinic
Baylor College of Medicine
University of Pennsylvania
University of California, San Diego
University of California, Los Angeles
University of Miami
Yale University
Beth Israel Deaconess Medical Center
University of Alabama at Birmingham
Georgetown University
University of Chicago
Icahn School of Medicine at Mount Sinai
University of Michigan
NYU Langone Health
University of Oklahoma
University of Illinois at Chicago
Duke University
Montefiore Medical Center
Rush University Medical Center
University of Florida
Medical College of Wisconsin
Weill Medical College of Cornell University
University of California, Davis
Oregon Health and Science University
University of Washington
Tulane University
University of California, San Francisco
Stanford University
University of North Carolina, Chapel Hill
Tufts Medical Center
Temple University
Loma Linda University
University Hospitals Cleveland Medical Center
University of Tennessee
University of Kentucky
The Cooper Health System
Hackensack Meridian Health
Ochsner Health System
University of Pittsburgh Medical Center
Indiana University Health Methodist Hospital
University of Texas, Southwestern Medical Center at Dallas
University Medical Center of Southern Nevada
Renown Health
New Jersey Medical School
Rutgers Robert Wood Johnson Medical School
Baylor Health Care System
Cook County Hospital
Northwestern
Hackensack mountainside hospital

Investigators

  • Principal Investigator: David E Leaf, MD, MMSc, Brigham and Women's Hospital
  • Study Director: Shruti Gupta, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000003

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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