COVID-19 Risk Stratification

Coronavirus Clinical Trial

Official title: COVID-19 Risk Stratification

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
• Severe Acute Respiratory Syndrome

• NCT number: NCT04339387
• Study type: Observational
• Source: Brigham and Women's Hospital
• Status: Completed
• Start date: March 1, 2020
• Completion date: April 26, 2020