ARDS Caused by COVID-19

Acute Respiratory Failure With Hypoxia Clinical Trial

Official title:

Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368975
• Other study ID #: COVID-19 ARDS
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Respiratory Failure With Hypoxia
• Hypoxia
• Respiratory Insufficiency

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