COVID-19 Risk Stratification

Mass General Brigham

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04339387

2020P000944

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

1,326 participants in 2 patient groups

Coronavirus Disease 2019 positive, suitable for discharge

Description:

Patients with Coronavirus Disease 2019 who do not require supplemental oxygen, do not require intensive care unit-level care, and do not die.

Coronavirus Disease 2019 positive, not suitable for discharge

Description:

Patients with Coronavirus Disease 2019 who do require supplemental oxygen, do require intensive care unit-level care, or do die.