CoronavirusNCT04339387
COVID-19 Risk Stratification
An observational study of Coronavirus and Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
- How many people
- 1,326 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 26 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2
- Age 18 and older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Suitable for discharge
Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die.
Measured: Duration of participation in cohort, expected to be between 1 day and 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Mar 2020
- Primary completion26 Apr 2020
- Study completion26 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339387
- Sponsor's protocol ID
- 2020P000944
- Status last verified
- Nov 2020
- First submitted
- 6 Apr 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators may provide reasonable requests for IPD. These requests will be reviewed by the study team and institution on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Risk Stratification
- ClinicalTrials.gov ID
- NCT04339387
- Acronym / sponsor ID
- 2020P000944
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,326 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 26 Apr 2020 (actual)
- Study completion
- 26 Apr 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2
- Age 18 and older
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: Undecided. Investigators may provide reasonable requests for IPD. These requests will be reviewed by the study team and institution on a case by case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suitable for discharge (time frame: Duration of participation in cohort, expected to be between 1 day and 20 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.