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Epidemiologic, Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV.

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. Identifier: NCT04552340
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:
The main purpose of this study is to identify possible predictor factor of mortality in patients affected by COVID-19 with respiratory failure needing oxygen therapy or ventilatory support. In addiction the study aims to identify factors related to: predisposition to SARS-CoV2 viral infection, different symptoms, response to therapy, predisposition to complications related to the disease. To this end, the haemodynamic parameters and all imaging reports will be evaluated and clinical and laboratory tests as well as cellular and molecular analyzes will be performed in the analyzed patients. In addition, investigations will be carried out on the profile of the alveolar or nasal microbiota and, if possible, of the metabolic products, and estimates on antibody titers.

Condition or disease Intervention/treatment
Covid19 Other: Patient with SAR-CoV-2 infection

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiologic, Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV: A Retrospective-Prospective Cohort Study.
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Patient with SAR-CoV-2 infection
    Study population The study cohort will be enrolled among patients referred to our the Humanitas Research Hospital, the Hospital Cliniche Gavazzeni (Bergamo) hospitals for SARS-CoV-2 screening who will/will not be hospitalized in wards dedicated to COVID-19 patients or admitted to intensive care unit.

Primary Outcome Measures :
  1. Mortality predictors in patients with Respiratory Failure who require oxygen therapy in the Intensive Care Unit or ventilatory support. [ Time Frame: 1 year ]
  2. Molecular profile of cell populations present in the BAL at early timepoint during SARS-CoV2 infection to predict severity of disease progression. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Type of possible complications such as AKI (Acute Kidney Injury) , infection, shock [ Time Frame: 1 year ]
  2. SARS-CoV2 mechanisms of infection in alveolar macrophages [ Time Frame: 3 years ]
  3. SARS-CoV2 genotypes in a cohort of patients representative of the Lombardy population [ Time Frame: 3 years ]
  4. Number of successful respiratory weaning [ Time Frame: 1 year ]

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:   Probability Sample
Study Population
Lack of informed consent according to local procedure per critically ill patients.

Inclusion Criteria:

  • Adult patients who underwent to a swab or BAL test for the presence of SAR-CoV-2 infection, aged ≥ 18 years;
  • Patients with Acute Respiratory Failure who require ventilatory support / patients admitted to the ICU;
  • Patients affected by COVID-19
  • Patients infected by SARS-CoV-2.

Exclusion Criteria:


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 identifier (NCT number): NCT04552340

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Contact: Maurizio Cecconi 0282244151

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Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Maurizio Cecconi         
Sponsors and Collaborators
Istituto Clinico Humanitas
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Principal Investigator: Maurizio Cecconi Humanitas Research Hospital
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Responsible Party: Istituto Clinico Humanitas Identifier: NCT04552340    
Other Study ID Numbers: 2485
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 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
Respiration Disorders
Respiratory Tract Diseases