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

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ClinicalTrials.gov Identifier: NCT04343898
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Montefiore Medical Center
Baylor College of Medicine
Baylor Health Care System
Beth Israel Deaconess Medical Center
University of Colorado, Denver
Cook County Hospital
The Cooper Health System
Duke University
Georgetown University
Hackensack mountainside hospital
Hackensack Meridian Health
Indiana University Health Methodist Hospital
Johns Hopkins University
Loma Linda University
Mayo Clinic
Medical College of Wisconsin
Northwestern
Weill Medical College of Cornell University
NYU Langone Health
Ochsner Health System
Oregon Health and Science University
Renown Health
Rush University Medical Center
New Jersey Medical School
Rutgers Robert Wood Johnson Medical School
Stanford University
Temple University
Tufts Medical Center
Tulane University
University of California, Davis
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of North Carolina, Chapel Hill
University Hospitals Cleveland Medical Center
University Medical Center of Southern Nevada
University of Alabama at Birmingham
University of Chicago
University of Florida
University of Illinois at Chicago
University of Kentucky
University of Miami
University of Michigan
University of Oklahoma
University of Pennsylvania
University of Pittsburgh Medical Center
University of Tennessee Health Science Center
University of Washington
University of Texas, Southwestern Medical Center at Dallas
Yale University
Information provided by (Responsible Party):
David Leaf, Brigham and Women's Hospital

Brief Summary:
Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

Condition or disease Intervention/treatment
Coronavirus Infection Other: No intervention

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    Observational


Primary Outcome Measures :
  1. 28-Day Mortality [ Time Frame: 28-days from the day of ICU admission ]

Secondary Outcome Measures :
  1. 60-Day Mortality [ Time Frame: 60-days from the day of ICU admission ]
  2. 90-Day Mortality [ Time Frame: 90-days from the day of ICU admission ]
  3. 1-Year Mortality [ Time Frame: 1 year from the day of ICU admission ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria (each of the following):

  1. Adults (aged ≥18 years)
  2. Confirmed diagnosis of COVID-19
  3. Hospitalized in the ICU for illness related to COVID-19
  4. Died or discharged from the hospital, or at least 14 days of survival data available from the time of ICU admission

Exclusion Criteria:

-None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343898


Contacts
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Contact: David E Leaf, MD, MMSc 617-525-7612 deleaf@bwh.harvard.edu
Contact: Shruti Gupta, MD, MPH sgupta21@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Icahn School of Medicine at Mount Sinai
Montefiore Medical Center
Baylor College of Medicine
Baylor Health Care System
Beth Israel Deaconess Medical Center
University of Colorado, Denver
Cook County Hospital
The Cooper Health System
Duke University
Georgetown University
Hackensack mountainside hospital
Hackensack Meridian Health
Indiana University Health Methodist Hospital
Johns Hopkins University
Loma Linda University
Mayo Clinic
Medical College of Wisconsin
Northwestern
Weill Medical College of Cornell University
NYU Langone Health
Ochsner Health System
Oregon Health and Science University
Renown Health
Rush University Medical Center
New Jersey Medical School
Rutgers Robert Wood Johnson Medical School
Stanford University
Temple University
Tufts Medical Center
Tulane University
University of California, Davis
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of North Carolina, Chapel Hill
University Hospitals Cleveland Medical Center
University Medical Center of Southern Nevada
University of Alabama at Birmingham
University of Chicago
University of Florida
University of Illinois at Chicago
University of Kentucky
University of Miami
University of Michigan
University of Oklahoma
University of Pennsylvania
University of Pittsburgh Medical Center
University of Tennessee Health Science Center
University of Washington
University of Texas, Southwestern Medical Center at Dallas
Yale University
Investigators
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Principal Investigator: David E Leaf, MD, MMSc Brigham and Women's Hospital
Study Director: Shruti Gupta, MD, MPH Brigham and Women's Hospital
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Responsible Party: David Leaf, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04343898    
Other Study ID Numbers: 2007P000003
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases