Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 9, 2020
First Posted Date April 13, 2020
Last Update Posted Date May 7, 2020
Actual Study Start Date April 1, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2020)
28-Day Mortality [ Time Frame: 28-days from the day of ICU admission ]
Original Primary Outcome Measures
 (submitted: April 10, 2020)
14-Day Mortality [ Time Frame: 14-days from the day of ICU admission ]
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2020)
  • 60-Day Mortality [ Time Frame: 60-days from the day of ICU admission ]
  • 90-Day Mortality [ Time Frame: 90-days from the day of ICU admission ]
  • 1-Year Mortality [ Time Frame: 1 year from the day of ICU admission ]
Original Secondary Outcome Measures
 (submitted: April 10, 2020)
  • 21-Day Mortality [ Time Frame: 21-days from the day of ICU admission ]
  • 28-Day Mortality [ Time Frame: 28-days from the day of ICU admission ]
  • 60-Day Mortality [ Time Frame: 60-days from the day of ICU admission ]
  • 90-Day Mortality [ Time Frame: 90-days from the day of ICU admission ]
  • 1-Year Mortality [ Time Frame: 1 year from the day of ICU admission ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19
Official Title Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19
Brief Summary Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.
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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Critically ill adults admitted to an intensive care unit for illness related to COVID-19
Condition Coronavirus Infection
Intervention Other: No intervention
Observational
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 5, 2020)
4000
Original Estimated Enrollment
 (submitted: April 10, 2020)
2000
Estimated Study Completion Date June 1, 2022
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: David E Leaf, MD, MMSc 617-525-7612 deleaf@bwh.harvard.edu
Contact: Shruti Gupta, MD, MPH sgupta21@bwh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04343898
Other Study ID Numbers 2007P000003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party David Leaf, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
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
Investigators
Principal Investigator: David E Leaf, MD, MMSc Brigham and Women's Hospital
Study Director: Shruti Gupta, MD, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date May 2020