COPD Prognosis in Covid Patients | NCT05274490

Studies
COPD Prognosis in Covid Patients

NCT05274490

Sponsor

Sohag University

Status

Completed

Last Update Posted

Mar 10, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Respiratory Failure

Interventions

intubation and mechanical ventilation

Countries

Egypt

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 2022

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

Jun 1, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Mar 5, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 10, 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

Mar 9, 2022

Last Update Posted Date

Mar 10, 2022Actual

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

In this prospective observational study, patients were selected from attendees of the intensive care unit. Different measures and outcomes had been studied and compared between patients with and without COPD, including hospitalization, medical costs, length of Intensive care stay, respiratory failure, and death rate.

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

Yes

Target Follow-Up Duration

2 Weeks

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
copd patients with covid infection			Procedure: intubation and mechanical ventilation
non-copd patients with covid infection			Procedure: intubation and mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intubation and mechanical ventilation	Procedure	patients who were in need were intubated and mechanically ventilated	copd patients with covid infection non-copd patients with covid infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SOFA score measurement in both groups	monitoring of SOFA items along two weeks	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
prognosis of the disease	hospital stay, nedd for mechanical ventilation	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: more than 20 years old.
- Both Males and females will be included.
- COPD patients.
- Recent confirmed the diagnosis with SARS-COV-2.

Exclusion Criteria:

Pregnancy.
- Malignancy.
- Immunodeficiency disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

male or female patient more than 20 years old, recently diagnosed covid positive

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Sohag University		Sohag			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007440	Intubation
D012121	Respiration, Artificial

Ancestor Terms

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques
D058109	Airway Management
D012151	Resuscitation

Browse Leaves

Not provided

Browse Branches

Not provided