Multiple-Center Retrospective Study of Severe and Critica... | NCT05422963

Studies
Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai

NCT05422963

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Jun 21, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

COVID-19

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2022Estimated

Primary Completion Date

Jun 10, 2023Estimated

Completion Date

Jun 10, 2023Estimated

First Submitted Date

Jun 13, 2022

First Submission Date that Met QC Criteria

Jun 15, 2022

First Posted Date

Jun 21, 2022Actual

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

Jun 15, 2022

Last Update Posted Date

Jun 21, 2022Actual

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

This study is to clarify the clinical characteristics of severe and critical COVID-19 from March 1st ,2022 to June 9th, 2022 in Shanghai and to explore the relationship between the characteristics and prognosis in these patients.

Detailed Description

To Describe the clinical characteristics of severe and critical COVID-19.
To analyze the relationship between the clinical characteristics and their clinical prognosis;
To analyze the relationship between clinical intervention and their clinical prognosis.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
severe and critical COVID-19		hospital admission time more than 24 hours meet the standard of definition of severe and critical COVID-19 in "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)"

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day mortality	28-day mortality of severe and critical COVID-19	one year

Secondary Outcomes

Measure	Description	Time Frame
60-day mortality	60-day mortality of severe and critical COVID-19	one year
ICU length of stay	ICU length of stay	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

severe and critical covid-19 patients who met the "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)"
admission time more than 24 hours

Exclusion Criteria:

admission time less than 24 hours

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

severe and critical COVID-19 patients admitted to specific medical systems in Shanghai.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Chen, PhD	Contact	+8613917403314		cy11530@rjh.com.cn

Overall Officials

Name	Affiliation	Role
Erzhen Chen, PhD	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

the data are not publicly available due to the privacy and ethical restriction.

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

Not provided

Browse Branches

Not provided