Accurate Classification System for Patients With COVID-19... | NCT04302688

Studies
Accurate Classification System for Patients With COVID-19 Pneumonitis

NCT04302688

Sponsor

Renmin Hospital of Wuhan University

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

669Actual

Phase

Not provided

Conditions

Pneumonitis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2019Actual

Primary Completion Date

Feb 10, 2020Actual

Completion Date

Mar 4, 2020Actual

First Submitted Date

Mar 7, 2020

First Submission Date that Met QC Criteria

Mar 7, 2020

First Posted Date

Mar 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2020

Last Update Posted Date

Mar 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The COVID-19 has a clustering morbidity trend and older people with chronic diseases are more likely to die, such as chronic renal insufficiency and chronic cardiovascular disease. We set up a COVID-19 pneumonia grading scale. The COVID-19 score system was validated to predict the clinical outcome of a patient.

Detailed Description

First we collect the medical records, according to the time sequence, the patients were divided into two groups, one is the model group, and the other is the validate group.
Responsible for the risk factor of regression equation according to the model. The patients were divided into three groups according to their total score of risk responsibility.
Compared with SEPSIS and CURB-65 grading system with the grading system we established.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

669Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
modeling cohort		The 445 patients were grouped in chronological order.
validating colort		The remaining 224 patients.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other		modeling cohort validating colort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival status	survival status as of February 24, 2020	10 December 2019 to 10 February 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with novel coronavirus pneumonia should be examined and diagnosed by CT and swab test of viral nucleic acid.

Exclusion Criteria:

Patients who should have died during the course of the disease, but the cause of death was unrelated to viral pneumonia.
Suspected patient review refers to the negative nucleic acid test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with novel coronavirus pneumonia, and all cases were collected from the People's Hospital of Wuhan University.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qiong Gong, MD.	Renmin Hospital of Wuhan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renmin Hospital of Wuhan University		Wuhan	Hubei	430060	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not going to share for the time being.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided