COVID-19 Risk Stratification

November 26, 2020 updated by: David Levine, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population includes every adult patient noted positive for severe acute respiratory syndrome coronavirus 2 in the entire Partners HealthCare system, a consortium hospitals and health care entities located in Massachusetts that cares for over 1.5 million patients each year.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Coronavirus Disease 2019 positive, suitable for discharge
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
Patients with Coronavirus Disease 2019 who do require supplemental oxygen, do require intensive care unit-level care, or do die.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suitable for discharge
Time Frame: 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.
Duration of participation in cohort, expected to be between 1 day and 20 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

April 26, 2020

Study Completion (Actual)

April 26, 2020

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P000944

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Investigators may provide reasonable requests for IPD. These requests will be reviewed by the study team and institution on a case by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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