COVID-19 Risk Stratification

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04339387

Collaborator

(none)

1,326

Enrollment

Location

1.8

Actual Duration (Months)

720.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Detailed Description

The investigators a-priori plan the following analysis:

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.

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 Design

Study Type:

Observational

Actual Enrollment :

1326 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

COVID-19 Risk Stratification

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Apr 26, 2020

Actual Study Completion Date :

Apr 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Levine, Associate Physician, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT04339387

Other Study ID Numbers:

2020P000944

First Posted:

Apr 9, 2020

Last Update Posted:

Nov 30, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Nov 30, 2020