COVID-19 Risk Stratification
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|ClinicalTrials.gov Identifier: NCT04339387|
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : November 30, 2020
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|Condition or disease|
|Coronavirus Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere|
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.
- 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|
|Actual Enrollment :||1326 participants|
|Official Title:||COVID-19 Risk Stratification|
|Actual Study Start Date :||March 1, 2020|
|Actual Primary Completion Date :||April 26, 2020|
|Actual Study Completion Date :||April 26, 2020|
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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2
- Age 18 and older
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339387
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Responsible Party:||David Levine, Associate Physician, Brigham and Women's Hospital|
|Other Study ID Numbers:||
|First Posted:||April 9, 2020 Key Record Dates|
|Last Update Posted:||November 30, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
RNA Virus Infections