COVID-19 Risk Stratification

• ClinicalTrials.gov Identifier: NCT04339387
• Recruitment Status: Completed
• First Posted: April 9, 2020
• Last Update Posted: November 30, 2020
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): David Levine, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: April 6, 2020
• First Posted Date: April 9, 2020
• Last Update Posted Date: November 30, 2020
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: April 26, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COVID-19 Risk Stratification
• Official Title: COVID-19 Risk Stratification
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 26, 2020): 1326
• Original Estimated Enrollment (submitted: April 6, 2020): 1500
• Actual Study Completion Date: April 26, 2020
• Actual Primary Completion Date: April 26, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04339387
• Other Study ID Numbers: 2020P000944
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• 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.

• Current Responsible Party: David Levine, Brigham and Women's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Brigham and Women's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Brigham and Women's Hospital
• Verification Date: November 2020