ARDS Caused by COVID-19 | NCT04368975

Studies
ARDS Caused by COVID-19

NCT04368975

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Apr 30, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Acute Respiratory Failure With Hypoxia

Interventions

Not provided

Countries

Spain

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

Apr 2020

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

Mar 12, 2020Actual

Primary Completion Date

Apr 21, 2020Actual

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Apr 29, 2020

First Posted Date

Apr 30, 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

Apr 29, 2020

Last Update Posted Date

Apr 30, 2020Actual

Name	Class
Ubikare	INDUSTRY

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

Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

Detailed Description

This is a multicenter, prospective, observational study in consecutive, mechanically ventilated patients with ARDS caused by COVID-19 (as defined by the Berlin criteria and confirmed COVID-19 infection in a respiratory tract sample), admitted into a network of 27 Spanish and Andorran intensive care units (ICUs). Clinical features, ventilatory management, and clinical outcomes will be examined

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

28 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discontinuation from mechanical ventilation		28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18 years or older
intubated and mechanically ventilated
confirmed COVID-19 infection in a respiratory tract sample
acute onset of ARDS, as defined by the Berlin criteria

Exclusion Criteria:

patients with non-confirmed SARS-CoV-2 infection according to WHO guidance
patients with no information on respiratory parameters
non- intubated patients

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

Critically ill patients with acute respiratory failure requiring invasive mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlos Ferrando, PhD	Contact	609892732		cmferrando@clinic.cat
Sara Darriba, PhD	Contact			darriba@clinic.cat

Overall Officials

Name	Affiliation	Role
Carlos Ferrando	Medical Research and Clinical Consulting	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ricard Mellado	Recruiting	Barcelona		08036	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32728965	Derived	Ferrando C, Suarez-Sipmann F, Mellado-Artigas R, Hernandez M, Gea A, Arruti E, Aldecoa C, Martinez-Palli G, Martinez-Gonzalez MA, Slutsky AS, Villar J; COVID-19 Spanish ICU Network. Clinical features, ventilatory management, and outcome of ARDS caused by COVID-19 are similar to other causes of ARDS. Intensive Care Med. 2020 Dec;46(12):2200-2211. doi: 10.1007/s00134-020-06192-2. Epub 2020 Jul 29.