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OpenTrials
Completed

NCT Number: NCT04339387

COVID-19 Risk Stratification

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.

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Key information

Conditions

Coronavirus Coronaviridae Infections Coronavirus Infections Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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