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Non-invasive Ventilatory Support of Patients Affected by COVID-19 (WARd-COVID)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382235
Recruitment Status : Active, not recruiting
First Posted : May 11, 2020
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:

Prospective, observational, multicenter study aiming to evaluate the number of COVID-19 pneumonia related patients treated with non-invasive ventilatory support outside the intensive care unit.

In addition, the study aims to obtain information related to the clinical characteristics and hospital results of these patients.


Condition or disease Intervention/treatment
Covid-19 Device: Non-invasive ventilatory support

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards
Actual Study Start Date : March 26, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Covid-19 related Pneumonia patients
The cohort is defined by subjects with a diagnosis of COVID 19-related pneumonia requiring non-invasive ventilatory support.
Device: Non-invasive ventilatory support
All non-invasive ventilatory support wll be recorded. All collected data is taken and monitored during normal clinical practice without adding any other tests.
Other Names:
  • High-flow nasal cannulas (HFNC)
  • Non-invasive ventilation (NIV)
  • Continuous positive airway pressure (CPAP) delivered with a face mask or helmet (helmet)




Primary Outcome Measures :
  1. The number of patients treated with non-invasive ventilation devices. [ Time Frame: Until patient discharge from the hospital (approximately 5 months) ]
    The first purpose of the study is to evaluate the number of COVID-19 related pneumonia patients treated with devices for non-invasive ventilation outside intensive care units.


Secondary Outcome Measures :
  1. Incidence of patients requiring mechanical ventilation [ Time Frame: Until patient discharge from the hospital (approximately 5 months) ]
    Assess the clinical characteristics of patients treated with devices for non-invasive ventilation using the following endpoint: incidence of patients requiring mechanical ventilation.

  2. Incidence of organ failure [ Time Frame: Until patient discharge from the hospital (approximately 5 months) ]
    Assess the clinical characteristics of patients treated with devices for non-invasive ventilation using the following endpoint: incidence of organ failure.

  3. Duration of hospitalization [ Time Frame: Until patient discharge from the hospital (approximately 5 months) ]
    Measure the hospital outcomes of patients treated with devices for non-invasive ventilation using the following endpoint: duration of hospitalization.

  4. Clinical outcome at hospital discharge [ Time Frame: Until patient discharge from the hospital (approximately 5 months) ]
    Measure the hospital outcomes of patients treated with devices for non-invasive ventilation using the following endpoint: clinical outcome at hospital discharge.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
The study will be conducted on all patients diagnosed with COVID-related pneumonia in need of non-invasive ventilatory support. Patients will be enrolled on single day (March 26, 2020 or March 31, 2020 chosen by the participating centers).
Criteria

Inclusion Criteria:

  • Age> = 18 years
  • Diagnosis of COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

Exclusion Criteria:

- Explicit refusal to participate in the study


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): NCT04382235


Locations
Show Show 34 study locations
Sponsors and Collaborators
University of Milano Bicocca
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04382235    
Other Study ID Numbers: WARd-COVID
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
Coronavirus
sars-covid-2
coronavirus infection