NCT04339387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

April 6, 2020

Last Update Submit

November 26, 2020

Conditions

CoronavirusCoronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Outcome Measures

Primary Outcomes (1)

  • 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.

    Duration of participation in cohort, expected to be between 1 day and 20 days.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

March 1, 2020

Primary Completion

April 26, 2020

Study Completion

April 26, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

US(1)