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Clinical Trials/NCT04339387
NCT04339387
Completed
Not Applicable

COVID-19 Risk Stratification

Brigham and Women's Hospital1 site in 1 country1,326 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronavirus
Sponsor
Brigham and Women's Hospital
Enrollment
1326
Locations
1
Primary Endpoint
Suitable for discharge
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
April 26, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Levine

Associate Physician

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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