Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in th... | NCT04941092

Studies
Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU

NCT04941092

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jul 12, 2022Actual

Enrollment

157Actual

Phase

Not provided

Conditions

ARDS
COVID-19 Acute Respiratory Distress Syndrome
Influenza

Interventions

no intervention

Countries

France

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 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

Jul 10, 2021Actual

Completion Date

Jul 10, 2021Actual

First Submitted Date

Jun 24, 2021

First Submission Date that Met QC Criteria

Jun 24, 2021

First Posted Date

Jun 28, 2021Actual

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

Jul 8, 2022

Last Update Posted Date

Jul 12, 2022Actual

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

Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.

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

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with ARDS induced by SARS CoV 2			Other: no intervention
patients with ARDS induced by influenza			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention, retrospective comparison	patients with ARDS induced by SARS CoV 2 patients with ARDS induced by influenza

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality		at 28 days

Secondary Outcomes

Measure	Description	Time Frame
length of stay in ICU		at 28 days
length of mechanical ventilation		at 28 days
length of vasopressors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients hospitalized in ICU
under mechanical ventilation
presenting an ARDS according to the Berlin definition
induced by either influenza or SARS CoV 2

Exclusion Criteria:

pregnant women
mechanical ventilation>48 hours before admission

Accepts Healthy Volunteers

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

patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France

- hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Nancy		Nancy		54000	France

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided