COVID-19 Risk Stratification

Coronavirus Clinical Trial

Official title:

COVID-19 Risk Stratification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339387
• Other study ID #: 2020P000944
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 26, 2020

Study information

• Verified date: November 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1326
• Est. completion date: April 26, 2020
• Est. primary completion date: April 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2

• Age 18 and older

Exclusion Criteria:

• None

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suitable for discharge	Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die.	Duration of participation in cohort, expected to be between 1 day and 20 days.