Predictive Factors COVID-19 Patients
- Conditions
- covid19
- Interventions
- Other: Predictive factors for clinical response in patients with COVID-19.
- Registration Number
- NCT04427345
- Lead Sponsor
- University of Milano Bicocca
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients 18 years old or above
- Diagnosis of SARS-CoV-2 pneumonia
- Explicit refusal to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Covid19 infection related patients Predictive factors for clinical response in patients with COVID-19. Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards.
- Primary Outcome Measures
Name Time Method Identify risk factors to build a prognostic score. Until patient discharge from the hospital (approximately 1 year) Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.
Identify risk factors for intra-hospital mortality. Until patient discharge from the hospital (approximately 1 year) Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.
- Secondary Outcome Measures
Name Time Method Describe the anti-viral therapies used commonly in this emergency in terms of efficacy Until patient discharge from the hospital (approximately 1 year). Description of efficacy of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement" Until patient discharge from the hospital (approximately 1 year) Description of the predictive factors for the clinical status of patients based on "Ordinal Scale for Clinical Improvement" defined by OMS (
Describe the anti-viral therapies used commonly used in this emergency in terms of safety Until patient discharge from the hospital (approximately 1 year). Description of safety of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
Predictive factors for the hospitalization duration. Until patient discharge from the hospital (approximately 1 year) Description of the predictive factors for the hospitalization duration.
Monitor the clinical course of the disease in discharged patients. 12 month after discharge Description of the disease clinical course in patients 12 months after discharge (mortality, neurological, respiratory and cardiac outcomes).
Trial Locations
- Locations (1)
ASST Monza-Ospedale San Gerardo
🇮🇹Monza, Italy