Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1326 participants
OBSERVATIONAL
2020-03-01
2020-04-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18 and older
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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David Levine
Associate Physician
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2020P000944
Identifier Type: -
Identifier Source: org_study_id