Effect of Corticosteroid Treatment on Prognosis in ARDS S... | NCT04586114

Studies
Effect of Corticosteroid Treatment on Prognosis in ARDS Secondary to Covid-19

NCT04586114

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Oct 19, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome Secondary to Covid-19

Interventions

Corticosteroids and Derivatives

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

May 31, 2020Actual

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Oct 8, 2020

First Submission Date that Met QC Criteria

Oct 13, 2020

First Posted Date

Oct 14, 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

Oct 16, 2020

Last Update Posted Date

Oct 19, 2020Actual

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

Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Early corticosteroid	Corticosteroid treatment within first seven days after ICU admission	Drug: Corticosteroids and Derivatives
Late corticosteroid	Corticosteroid treatment later than seventh day's after ICU admission	Drug: Corticosteroids and Derivatives
No corticosteroid	No corticosteroid treatment during ICU stay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Corticosteroids and Derivatives	Drug	Any systemic corticosteroid treatment administrated during ICU stay	Early corticosteroid Late corticosteroid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality in ICU	Mortality rates in ICU in each group	within ICU stay, on average 15 days

Secondary Outcomes

Measure	Description	Time Frame
Mortality d28	mortality at day 28 after ICU admission	28 days
acquired infections incidence	cumulative incidence of infection acquired during ICU stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU hospitalized with acute respiratory distress syndrome secondary to Sars-Cov-2 infection diagnosed by PCR test
Hospitalized from 01/03/2020 to 30/04/2020

Exclusion Criteria:

Mechanical ventilation more than 48 hours at admission
Transfert to another ICU during stay for bed management
Corticosteroid treatment at 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

Patient more than 18 years old hospitalized in ICU from 01/03/2020 to 30/04/2020 with acute respiratory distress syndrome secondary to Sars-Cov-2 infection without any corticosteroid treatment before admission, excluding patients with mechanical ventilation more than 48 hours before admission and patients transferred to other ICU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastien GIBOT	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Central, Service de Reanimation Medicale		Nancy		54000	France

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

Intervention Browse Module

MeSH Terms

ID	Term
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided