NCT04368975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 27, 2020

Last Update Submit

April 29, 2020

Conditions

Acute Respiratory Failure With Hypoxia

Outcome Measures

Primary Outcomes (1)

  • Discontinuation from mechanical ventilation

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients with acute respiratory failure requiring invasive mechanical ventilation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ricard Mellado

Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32728965DERIVED

Study Officials

  • Carlos Ferrando

    Medical Research and Clinical Consulting

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Ferrando, PhD

CONTACT

609892732cmferrando@clinic.cat

Sara Darriba, PhD

CONTACT

darriba@clinic.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgical Intensive Care Unit

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

March 12, 2020

Primary Completion

April 21, 2020

Study Completion

December 31, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

ES(1)