CT Scores Predict Mortality in 2019-nCoV Pneumonia | NCT04284046

Studies
CT Scores Predict Mortality in 2019-nCoV Pneumonia

NCT04284046

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Feb 25, 2020Actual

Enrollment

39Actual

Phase

Not provided

Conditions

CT Scores Predict Mortality in 2019-nCoV Pneumonia

Interventions

CT score

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

Feb 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

Jan 31, 2020Actual

Primary Completion Date

Feb 18, 2020Actual

Completion Date

Feb 18, 2020Actual

First Submitted Date

Feb 22, 2020

First Submission Date that Met QC Criteria

Feb 22, 2020

First Posted Date

Feb 25, 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

Feb 22, 2020

Last Update Posted Date

Feb 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruilan Wang, PhD, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

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

While 2019-nCoV nucleic acid swab tests has high false positives rate, How to diagnose 2019-nCoV pneumonia and predict prognosis by CT is very important.In this retrospective single-center study, we consecutively included suspected 2019-nCoV pneumonia critical cases in the intensive care unit of Wuhan third hospital from January 31, 2020 to February 16, 2020. The cases were confirmed by real-time RT-PCR, and all patients were evaluated with CT, cutoff values were obtained according to the Yoden index, and were divided into high CT score group and low CT score group. Epidemiological, demographic, clinical, and laboratory data were collected.

Detailed Description

Not provided

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

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High CT score			Other: CT score
Low CTscore			Other: CT score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT score	Other	CT score = normal lung tissue (%) ×1 + GGO (%) ×2 + consolidation (%) ×3	High CT score Low CTscore

Measure	Description	Time Frame
7-day mortality		7-day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients suspected of 2019 novel coronavirus infection.

Exclusion Criteria:

patients' data are not available.

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

all patients suspected of 2019 novel coronavirus infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan third hospital		Wuhan	Hubei		China