Predictive Factors COVID-19 Patients (MI-COVID)

May 19, 2022 updated by: University of Milano Bicocca

Predictive Clinical Response Factors in COVID-19 Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy
        • ASST Monza-Ospedale San Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study involves patients admitted to San Gerardo Hospital from March 1, 2020 to May 31, 2020. The minimum expected follow-up will be one year for all patients.

Given the nature of the study, no formal calculation of the sample size was made, nor was a sample size predefined. However, given the recruiting potential of the center which in March saw on average 30-60 hospitalizations due to SARS-CoV-2 per day, even considering a progressive decrease in access, it is assumed that the proportion of patients who will be included in the study will exceed 1000 units.

Description

Inclusion Criteria:

  • Patients 18 years old or above
  • Diagnosis of SARS-CoV-2 pneumonia

Exclusion Criteria:

  • Explicit refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid19 infection related patients
Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards.
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify risk factors for intra-hospital mortality.
Time Frame: 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.
Until patient discharge from the hospital (approximately 1 year)
Identify risk factors to build a prognostic score.
Time Frame: 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 guides the therapeutic choices.
Until patient discharge from the hospital (approximately 1 year)
Identify risk factors to build a prognostic score.
Time Frame: 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.
Until patient discharge from the hospital (approximately 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors for the hospitalization duration.
Time Frame: Until patient discharge from the hospital (approximately 1 year)
Description of the predictive factors for the hospitalization duration.
Until patient discharge from the hospital (approximately 1 year)
Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement"
Time Frame: 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 (
Until patient discharge from the hospital (approximately 1 year)
Describe the anti-viral therapies used commonly in this emergency in terms of efficacy
Time Frame: 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.
Until patient discharge from the hospital (approximately 1 year).
Describe the anti-viral therapies used commonly used in this emergency in terms of safety
Time Frame: 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.
Until patient discharge from the hospital (approximately 1 year).
Monitor the clinical course of the disease in discharged patients.
Time Frame: 12 month after discharge
Description of the disease clinical course in patients 12 months after discharge (mortality, neurological, respiratory and cardiac outcomes).
12 month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Actual)

May 12, 2022

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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