Chest Radiography in COVID-19 Patients | NCT04485338

Studies
Chest Radiography in COVID-19 Patients

NCT04485338

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Last Update Posted

Feb 16, 2022Actual

Enrollment

139Actual

Phase

Not provided

Conditions

Covid19

Interventions

Not provided

Countries

Netherlands

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

Feb 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

Aug 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Jul 23, 2020

First Submission Date that Met QC Criteria

Jul 23, 2020

First Posted Date

Jul 24, 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

Feb 15, 2022

Last Update Posted Date

Feb 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Marcus J. Schultz, Prof. M.J. Schultz, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

Name	Class
University of Bari Aldo Moro	OTHER
Mahidol University	OTHER
Universitair Ziekenhuis Brussel	OTHER
Chonburi hospital

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

To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.

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

139Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.		90 days

Secondary Outcomes

Measure	Description	Time Frame
The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19		90 days
Number of ventilator-free day and alive at day 28 (VFD)		28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to an ICU participating in this study between December 1, 2019 and May 31, 2020
Having had received invasive ventilation
Having had received at least one chest radiograph under invasive ventilation
Confirmed novel coronavirus diseases (COVID-19)

Exclusion Criteria:

- Age < 18 years

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Severe COVID-19 patients under invasive ventilation who received as part of standard care and routine imaging.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcus J. Schultz, Prof.	Amsterdam University Medical Centers, location 'AMC'	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC location AMC		Amsterdam		1105AZ	Netherlands

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

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