COVID-19 Risk Stratification
Purpose
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.
Conditions
- Coronavirus
- Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 - Age 18 and older
Exclusion Criteria
- None
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
More Details
- NCT ID
- NCT04339387
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
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.