Study for Novel Coronavirus Pneumonia (NCP) | NCT04283396

Studies
Study for Novel Coronavirus Pneumonia (NCP)

NCT04283396

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Mar 17, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Novel Coronavirus Pneumonia

Interventions

systemic treatment

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2020Actual

Primary Completion Date

May 30, 2020Estimated

Completion Date

Jul 30, 2020Estimated

First Submitted Date

Feb 13, 2020

First Submission Date that Met QC Criteria

Feb 20, 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

Mar 15, 2020

Last Update Posted Date

Mar 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yang Jin, Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

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 develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

Detailed Description

By retrospectively analyzing the clinical epidemiological characteristics of the novel coronavirus pneumonia and the current diagnosis and treatment schemes, as well as in-depth analyzing the disease development process and outcome trends of NCP patients to develop practical and effective clinical diagnosis and treatment schemes and provide guarantee for the rapid control of the epidemic.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
systemic treatment	Combination Product	Oxygen therapy, antiviral therapy, antibiotics, hormones, globulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recovery	Number of patients recover from novel coronavirus pneumonia	up to 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients confirmed with novel coronavirus pneumonia. The Diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)";

Exclusion Criteria:

Physician judged the patient was not suitable for this clinical trial.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients confirmed with novel coronavirus pneumonia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang Jin	Contact	13554361146		whunjy@126.com
Jiancai Wu	Contact	02785726685

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union hospital	Recruiting	Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020360	Neoadjuvant Therapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided