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ARDS Caused by COVID-19

NCT ID: NCT04368975

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-12

Study Completion Date

2020-12-31

Brief Summary

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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

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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

Conditions

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Acute Respiratory Failure With Hypoxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ubikare

INDUSTRY

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Carlos Ferrando Ortolá

Head of Surgical Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Ferrando

Role: PRINCIPAL_INVESTIGATOR

Medical Research and Clinical Consulting

Locations

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Ricard Mellado

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carlos Ferrando, PhD

Role: CONTACT

Phone: 609892732

Email: [email protected]

Sara Darriba, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Carlos Ferrando

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32728965 (View on PubMed)

Other Identifiers

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COVID-19 ARDS

Identifier Type: -

Identifier Source: org_study_id