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ARDS Caused by COVID-19

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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

Tracking Information
First Submitted Date April 27, 2020
First Posted Date April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date March 12, 2020
Actual Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2020)
Discontinuation from mechanical ventilation [ Time Frame: 28 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ARDS Caused by COVID-19
Official Title Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19
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.
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
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Critically ill patients with acute respiratory failure requiring invasive mechanical ventilation
Condition Acute Respiratory Failure With Hypoxia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Ferrando C, Suarez-Sipmann F, Mellado-Artigas R, Hernández M, Gea A, Arruti E, Aldecoa C, Martínez-Pallí G, Martínez-González 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. Erratum in: Intensive Care Med. 2020 Dec 2;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 29, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Actual Primary Completion Date April 21, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Carlos Ferrando, PhD 609892732 cmferrando@clinic.cat
Contact: Sara Darriba, PhD darriba@clinic.cat
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04368975
Other Study ID Numbers COVID-19 ARDS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Carlos Ferrando Ortolá, Hospital Clinic of Barcelona
Study Sponsor Hospital Clinic of Barcelona
Collaborators Ubikare company
Investigators
Principal Investigator: Carlos Ferrando Medical Research and Clinical Consulting
PRS Account Hospital Clinic of Barcelona
Verification Date April 2020