We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Risk Stratification

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339387
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
David Levine, Brigham and Women's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

Condition or disease
Coronavirus Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Detailed Description:

The investigators a-priori plan the following analysis:

  1. Derivation and Retrospective Validation.

    • Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 beginning March 1, 2020 until approximately 1000 patients are included.
    • Use 75% of this cohort to develop a simple risk-score that prognosticates a patient's suitability for discharge (no supplemental oxygen, no intensive care unit, and no death). Use multivariable logistic regression with forward selection informed by clinical judgement to choose variables a priori that emphasizes readily available data and easy calculation for use at the point of care.
    • Use 25% of this cohort to retrospectively validate the risk-score.

  2. Prospective Validation.

    • Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 as soon as the derivation cohort in step 1 is assembled. Include approximately 250 patients.
    • Use this sample to prospectively validate the risk-score developed in part 1.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1326 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: COVID-19 Risk Stratification
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : April 26, 2020
Actual Study Completion Date : April 26, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Coronavirus Disease 2019 positive, suitable for discharge
Patients with Coronavirus Disease 2019 who do not require supplemental oxygen, do not require intensive care unit-level care, and do not die.
Coronavirus Disease 2019 positive, not suitable for discharge
Patients with Coronavirus Disease 2019 who do require supplemental oxygen, do require intensive care unit-level care, or do die.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Suitable for discharge [ Time Frame: Duration of participation in cohort, expected to be between 1 day and 20 days. ]
    Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
The study population includes every adult patient noted positive for severe acute respiratory syndrome coronavirus 2 in the entire Partners HealthCare system, a consortium hospitals and health care entities located in Massachusetts that cares for over 1.5 million patients each year.
Criteria

Inclusion Criteria:

  • Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2
  • Age 18 and older

Exclusion Criteria:

  • None
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04339387


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: David Levine, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04339387    
Other Study ID Numbers: 2020P000944
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Investigators may provide reasonable requests for IPD. These requests will be reviewed by the study team and institution on a case by case basis.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections