ARDS Caused by COVID-19
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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 |
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Recruitment Status :
Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
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Sponsor:
Hospital Clinic of Barcelona
Collaborator:
Ubikare company
Information provided by (Responsible Party):
Carlos Ferrando Ortolá, Hospital Clinic of Barcelona
| Tracking Information | |||||||||
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| 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 |
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 |
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| 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;:. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Carlos Ferrando Ortolá, Hospital Clinic of Barcelona | ||||||||
| Study Sponsor | Hospital Clinic of Barcelona | ||||||||
| Collaborators | Ubikare company | ||||||||
| Investigators |
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| PRS Account | Hospital Clinic of Barcelona | ||||||||
| Verification Date | April 2020 | ||||||||