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

NCT04552340 | Unknown

• 1 other identifier: 2485
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Mortality predictors in patients with Respiratory Failure who require oxygen therapy in the Intensive Care Unit or ventilatory support.

  1 year

• Molecular profile of cell populations present in the BAL at early timepoint during SARS-CoV2 infection to predict severity of disease progression.

  1 year

Secondary Outcomes (4)

• Type of possible complications such as AKI (Acute Kidney Injury) , infection, shock

  1 year

• SARS-CoV2 mechanisms of infection in alveolar macrophages

  3 years

• SARS-CoV2 genotypes in a cohort of patients representative of the Lombardy population

  3 years

• Number of successful respiratory weaning

  1 year

Interventions

Patient with SAR-CoV-2 infection OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lack of informed consent according to local procedure per critically ill patients.

You may qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maurizio Cecconi

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Cecconi

CONTACT

0282244151; maurizio.cecconi@hunimed.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 17, 2020
• Study Start: March 16, 2020
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-09

Locations

IT (1)