NCT04427345

Predictive Factors COVID-19 Patients

Predictive Clinical Response Factors in COVID-19 Patients

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a monocentric retro-prospective observational study that will be conducted on all COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.

Detailed description

BACKGROUND: The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing the health systems of the most advanced countries. Clinicians are faced with a new pathology of an emerging virus. There is therefore an urgent need to collect real-time clinical data that informs about outcome predictive variables. Furthermore, there are currently no antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are being used with drugs already in use for other pathologies that have shown some efficacy in vitro, and some treatments obtained for compassionate use with other drugs that are being tested. It is more than ever necessary to collect clinical practice data both retrospectively on the work done so far, and in a longitudinal perspective, and analyze them quickly to optimize current treatments and define protocols for the future. Having a good clinical data base also offers the possibility of collaborating with numerous international networks on translational research, which aims to correlate clinical data with virological and immunological data, aimed at the rapid identification of possible specific viral virulence factors, or particular immune structures of the guests who once again define the final clinical outcome. STUDY DESIGN: All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study. After patient signs the informed consent, the following data will be collected: * birth data * sex * demographic data * comorbidity * blood chemistry data at the entrance A series of variables will then be collected relating to the treatment procedure, the therapies, the team's choice to maximize the care ceiling in the individual patient and the entire clinical study of the patient. STATISTICAL ANALISYS: Central tendency and dispersion measurements will be used for descriptive analysis of continuous variables while absolute and relative frequencies will be used to describe categorical variables.

Conditions

• covid19

Interventions

Type	Name	Description
OTHER	Predictive factors for clinical response in patients with COVID-19.	Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care .

Timeline

• Start date: 2020-04-30
• Primary completion: 2021-05-01
• Completion: 2022-05-12
• First posted: 2020-06-11
• Last updated: 2022-05-26

Locations

1 site across 1 country: Italy