A Novel Nomogram to Predict Severity of COVID-19 | NCT04366024

Studies
A Novel Nomogram to Predict Severity of COVID-19

NCT04366024

Sponsor

Xinqiao Hospital of Chongqing

Status

Completed

Last Update Posted

Feb 23, 2024Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

COVID-19 Disease
Nomogram Model

Interventions

other

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 2024

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 17, 2020Actual

Primary Completion Date

Aug 30, 2020Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Apr 21, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 28, 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, 2024

Last Update Posted Date

Feb 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianguo Sun, Deputy Director,Head of Oncology department, Principal Investigator, Clinical Professor, Xinqiao Hospital of ChongqingPrincipal Investigator

Lead Sponsor

Xinqiao Hospital of ChongqingOTHER

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

Investigators use clinical data from a large sample of COVID-19 disease patients to screen out biomarkers associated with disease severity. Then, a novel nomogram model will be established to predict covid-19 disease severity, which could provide important assistance and supplement for clinical work. In the case of extremely shortage of front-line medical resources, patients with potential severe diseases will be timely treated with the help of the novel nomogram model.

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

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observed group		COVID-19 disease patients who were detected by RT-PCR and CT imaging.	Other: other

Interventions

Name	Type	Description	Arm Group Labels	Other Names
other	Other	clinical diagnosis	Observed group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the consistency of predicted severe rate and observed severe rate of COVID-19 patients	We aim to use the clinical data of COVID-19 patients to construct a nomogram model to predict the severe rate of each patient, then the the consistency of predicted severe rate and observed severe rate will be evaluated by calibration plot.	up to 3 months
Duration of severe illness	the duration of severe illness of each patient will evaluated	up to 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 disease patients confirmed by virus nucleic acid RT-PCR and CT

Exclusion Criteria:

unconfirmed suspected cases
Patients during pregnancy and lactation
incomplete clinical data
investigators considered patients ineligible for the trial
Child patients

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

COVID-19 disease patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinqiao Hospital of Chongqing		Chongqing	Chongqing Municipality	400000	China