COVID-19 Risk Stratification

Completed

• Conditions: Coronavirus; Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

• Registration Number: NCT04339387
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-09
• Primary Completion: 2020-04-26
• Study Completion: 2020-04-26
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1326

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Suitable for discharge	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States