Multifactorial Evaluation of COVID-19 Respiratory Reliquates | NCT05607069

Studies
Multifactorial Evaluation of COVID-19 Respiratory Reliquates

NCT05607069

Sponsor

University of Turin, Italy

Status

Unknown status

Last Update Posted

Aug 2, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

COVID-19 Respiratory Infection

Interventions

Not provided

Countries

Italy

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

Jul 2023

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

May 28, 2022Actual

Primary Completion Date

May 28, 2023Actual

Completion Date

May 28, 2024Estimated

First Submitted Date

Nov 4, 2022

First Submission Date that Met QC Criteria

Nov 4, 2022

First Posted Date

Nov 7, 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

Aug 1, 2023

Last Update Posted Date

Aug 2, 2023Actual

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

The present study aims to evaluate how commonly diagnostic tools employed in the preoperative evaluation of respiratory function in thoracic surgery can identify pathological alteration due to a previous SARS-CoV-2 infection. In particular, the investigators will gather information concerning imaging (lung ct and lung ultrasound), arterial blood gas analysis, and pulmonary function tests.

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

50Estimated

Label	Type	Description	Intervention Names
COVID-19 previous infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensibility of preoperative evaluation in identifying pathological sequelae due to SARS-Cov2 infection		12 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

previous SARS-Cov2 infection
awaiting lung resection surgery

Exclusion Criteria:

less than 18 years of age
unable to consent to enroll
refuse to enroll

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The study will enroll patients scheduled for lung resection surgery that had a documented previous SARS-Cov2 infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Città della Salute e della Scienza di Torino	Recruiting	Turin		10100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided