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ARDS Caused by COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368975
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Ubikare company
Information provided by (Responsible Party):
Carlos Ferrando Ortolá, Hospital Clinic of Barcelona

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.

Condition or disease
Acute Respiratory Failure With Hypoxia

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19
Actual Study Start Date : March 12, 2020
Actual Primary Completion Date : April 21, 2020
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  1. Discontinuation from mechanical ventilation [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients with acute respiratory failure requiring invasive mechanical ventilation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368975


Contacts
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Contact: Carlos Ferrando, PhD 609892732 cmferrando@clinic.cat
Contact: Sara Darriba, PhD darriba@clinic.cat

Locations
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Spain
Ricard Mellado Recruiting
Barcelona, Spain, 08036
Contact: Carlos Ferrando    609892732    cmferrando@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Ubikare company
Investigators
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Principal Investigator: Carlos Ferrando Medical Research and Clinical Consulting
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlos Ferrando Ortolá, Head of Surgical Intensive Care Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04368975    
Other Study ID Numbers: COVID-19 ARDS
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory