The Clinical Difference Between the Nonfatal Patients and... | NCT04403009

Studies
The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19

NCT04403009

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Status

Completed

Last Update Posted

Mar 7, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Coronavirus Disease 2019
Character of the Severe Patients

Interventions

no intervention

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 2023

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

Feb 1, 2020Actual

Primary Completion Date

Jun 6, 2020Actual

Completion Date

Jun 20, 2020Actual

First Submitted Date

Apr 21, 2020

First Submission Date that Met QC Criteria

May 24, 2020

First Posted Date

May 27, 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 4, 2023

Last Update Posted Date

Mar 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhang Jianheng, Principal Investigator, The First Affiliated Hospital of Guangzhou Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Guangzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to compare the clinical information (laboratory and radiologic characteristics)of nonfatal participants and fatal cases. The investigators wish figure out the clinical character of the fatal participants. The result may help the physician to find the fatal patients with COVID-19 more easily. The fatal patients with COVID-19 could be treated early.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
the nonsevere Coronavirus Disease 2019 Patients			Other: no intervention
the severe Coronavirus Disease 2019 Patients			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	the nonsevere Coronavirus Disease 2019 Patients the severe Coronavirus Disease 2019 Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lymphocyte cell	the counting of Lymphocyte(counts/L)	2 month
d-dimer	d-dimer（mg/L）	2 month
PLT	the counting of Platelets（(counts/L)）	2 month
CRP	the level of C-reactive protein (mg/uL)	2 month
LDH	lactate dehydrogenase ( U/L)	2 month
CK	creatine kinase (U/L)	2 month
PT	prothrombin time(second)	2 month
ALT	alanine aminotransferase(U/L)	2 month
AST	aspartate aminotransferase(U/L)	2 month
NK cell

Secondary Outcomes

Measure	Description	Time Frame
the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases	CT scan feature	2 months

Other Outcomes

Measure	Description	Time Frame
SPO2	oxygen Saturation	2 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients with Coronavirus Disease 2019
Positive result on real-time reverse-transcriptase-polymerase-chain-reaction
Positive result on chest computed tomography

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The patients with Coronavirus Disease 2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jianheng zhang, MD	First Afiliated hospital of Guangzhou medical university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Guangzhou Medical University		Guanzhou	Guangdong	520120	China
Hankou Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

It is not decided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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