NCT04339387

COVID-19 Risk Stratification

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,326 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus
• Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-04-26
• Completion: 2020-04-26
• First posted: 2020-04-09
• Last updated: 2020-11-30

Locations

1 site across 1 country: United States