STOP-COVID: Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19
Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04343898
Collaborator
Icahn School of Medicine at Mount Sinai (Other), Montefiore Medical Center (Other), Baylor College of Medicine (Other), Baylor Health Care System (Other), Beth Israel Deaconess Medical Center (Other), University of Colorado, Denver (Other), Cook County Hospital (Other), The Cooper Health System (Other), Duke University (Other), Georgetown University (Other), Hackensack mountainside hospital (Other), Hackensack Meridian Health (Other), Indiana University Health Methodist Hospital (Other), Johns Hopkins University (Other), Loma Linda University (Other), Mayo Clinic (Other), Medical College of Wisconsin (Other), Northwestern (Other), Weill Medical College of Cornell University (Other), NYU Langone Health (Other), Ochsner Health System (Other), Oregon Health and Science University (Other), Renown Health (Other), Rush University Medical Center (Other), New Jersey Medical School (Other), Rutgers Robert Wood Johnson Medical School (Other), Stanford University (Other), Temple University (Other), Tufts Medical Center (Other), Tulane University (Other), University of California, Davis (Other), University of California, Los Angeles (Other), University of California, San Diego (Other), University of California, San Francisco (Other), University of North Carolina, Chapel Hill (Other), University Hospitals Cleveland Medical Center (Other), University Medical Center of Southern Nevada (Other), University of Alabama at Birmingham (Other), University of Chicago (Other), University of Florida (Other), University of Illinois at Chicago (Other), University of Kentucky (Other), University of Miami (Other), University of Michigan (Other), University of Oklahoma (Other), University of Pennsylvania (Other), University of Pittsburgh Medical Center (Other), University of Tennessee Health Science Center (Other), University of Washington (Other), University of Texas, Southwestern Medical Center at Dallas (Other), Yale University (Other)
5,154
1
28
184.1
Study Details
Study Description
Brief Summary
Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Actual Enrollment
:
5154 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
:
Apr 1, 2020
Actual Primary Completion Date
:
Aug 1, 2020
Anticipated Study Completion Date
:
Aug 1, 2022
Outcome Measures
Primary Outcome Measures
- 28-Day Mortality [28-days from the day of ICU admission]
Secondary Outcome Measures
- 60-Day Mortality [60-days from the day of ICU admission]
- 90-Day Mortality [90-days from the day of ICU admission]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria (each of the following):
-
Adults (aged ≥18 years)
-
Laboratory-confirmed diagnosis of COVID-19
-
Hospitalized in the ICU for illness related to COVID-19
Exclusion Criteria:
-None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | 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
- Principal Investigator: David E Leaf, MD, MMSc, Brigham and Women's Hospital
- Study Director: Shruti Gupta, MD, MPH, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.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:
Apr 13, 2020
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: