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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04368975
Other study ID # COVID-19 ARDS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 12, 2020
Est. completion date December 31, 2020

Study information

Verified date April 2020
Source Hospital Clinic of Barcelona
Contact Carlos Ferrando, PhD
Phone 609892732
Email cmferrando@clinic.cat
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2020
Est. primary completion date April 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Ricard Mellado Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona Ubikare company

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Discontinuation from mechanical ventilation 28 days
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