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COVID-19 Risk Stratification

COVID-19 Risk Stratification

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04339387
Enrollment
1326
Registered
2020-04-09
Start date
2020-03-01
Completion date
2020-04-26
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Suitable for dischargeDuration 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026