Risk Identification of Long-term Complications | NCT06235866

Studies
Risk Identification of Long-term Complications

NCT06235866

Sponsor

Wuhan Central Hospital

Status

Unknown status

Last Update Posted

May 8, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Severe COVID-19

Interventions

Pulmonary rehabilitation

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

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Nov 1, 2025Estimated

First Submitted Date

Oct 8, 2023

First Submission Date that Met QC Criteria

Jan 29, 2024

First Posted Date

Feb 1, 2024Actual

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

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigators retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and then establish a prediction model for long-term complications in patients with severe COVID-19, and strengthen follow-up to improve the prognosis of patients.

Detailed Description

At present, there is a lack of prediction models for the long-term complications of severe COVID-19. Therefore, the investigators used the hospital big data platform to retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and conducted cohort follow-up of the changes in lung function including FEV1, FVC，FEV1% and DLCO, etc and and high-resolution CT of patients after discharge. COX model and other statistical methods were used to establish a prediction model for long-term complications of severe COVID-19, and early identification and intervention, strengthen follow-up, and improve the prognosis of patients.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Follow-up cohort of patients with severe COVID-19		The scores of various scales, pulmonary function and imaging changes of patients with severe COVID-19 were collected at 3 months, 6 months and 12 months after rehabilitation and discharge.	Other: Pulmonary rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehabilitation	Other	According to the pulmonary rehabilitation guidelines, patients with severe COVID-19 were given regular rehabilitation treatment, including breathing exercises and physical rehabilitation exercises.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung function	Pulmonary function indicators improved gradually	1 year
Imaging of the lung	The residual lesions in the lung were gradually absorbed	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient met the diagnostic criteria for severe COVID-19

Exclusion Criteria:

Pregnant women Patients who died of COVID-19 Patients younger than 18 years of age without pulmonary CT

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with severe COVID-19 in our hospital from December 8, 2022 to January 31, 2023 were enrolled

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Follow-up of patients with severe COVID-19		Wuhan		430000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

The project confidentiality agreement was observed, but the IPD could be made public after the study was completed.

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