Predictors of Cardiovascular Risk in Covid-19 Patients During Acute Disease and at Short Term Follow-up

NCT04371289 | Completed

• 1 other identifier: 09C022
• Study Type: observational
• Target: 4,356
• Locations: 1 country
• Sites: 1

Brief Summary

Northern Italy, and particularly Lombardy, is one of the regions of the world mostly affected by COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To investigate the still largely unknown pathophysiology of this disease, we have built a consortium of Italian Hospitals to include a large cohort of COVID-19 patients from mild out-patients managed by GPs to inpatients developing mild, moderate or severe disease assessed both in hospital and at a 3-6 month follow-up visit). Consortium partners have a wide expertise to allow for 1) comprehensive assessment of risk factors for severe COVID-19 syndrome; 2) study the pathophysiology of its cardio-respiratory manifestations; 3) estimate risk scores also with artificial intelligence and 4) assess its clinical immunoinflammatory and cardiorespiratory sequelae in discharged patients at short term follow-up. To this aim, we will

1. 1.Enroll around 5500 COVID-19 patients (1000 outpatients and 4500 in-patients), which will allow to:
2. 2.Use an electronic CRF (on RedCap) to record clinical, biohumoral and imaging data of inpatients with COVID-19 of various severity to explore the prognostic and pathophysiological role of immunologic factors, activation of blood coagulation, endothelial dysfunction, inflammatory response, genetic (ni particular X-linked), hormonal and metabolic factors, comorbidities and acute cardiac damage. Blood samples will be collected. We will also use machine learning techniques to develop multivariable models for patients' risk stratification
3. 3.A follow-up visit at 3-6 months after discharge will be performed to identify residual clinical consequences that might affect long-term prognosis.

Conditions

COVID-19; Cardiovascular Risk Factor

Keywords

Angiotensin receptor-blocker; ACE inhibitors drugs; Co-morbidities; Inflammatory cytokines; Genetic factors; Metabolic factors; Cardiac damage; Artificial Intelligence

Outcome Measures

Primary Outcomes (3)

• Predictive modeling of in-hospital outcome

  To obtain a multivariable model based on anthropometric, clinical and therapeutic variables that will allow to predict the development of severe COVID-19 and its complications

  12 Months

• Clinical, pathophysiological and molecular mechanisms

  To Identify the role of selected clinical, pathophysiological and molecular mechanisms in the development of COVID-19 disease and its clinical manifestations of different severity

  12 Months

• Short -Term Sequelae

  To Identify the clinical, immunological, inflammatory, viral, cardiorespiratory consequences of COVD-19 that may persist a few months after discharge and may affect mid- and long-term prognosis

  12 Months

Study Arms (2)

COVID-19 outpatients

Mild COVID-19 outpatients managed by General Practitioners in Northern Italy (Lombardy)

COVID-19 inpatients

Mild, moderate and severe inpatients managed in different Italian Hospitals, mostly in Northern Italy (Lombardy)

Eligibility Criteria

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

Study Population

Outpatients and hospitalized patients with confirmed COVID-19 infection, recruited by General Practitioners or in Italian hospitals (mostly in Northern Italy), respectively

You may qualify if:

• Positivity to the test for COVID-19 and / or chest Xray or CT positive for interstitial pneumonia compatible with infection with this virus, regardless of the severity of the infection and the need or not for hospitalization
• Informed consent freely granted also verbally

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

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

• Gianfranco Parati, MD, PhD

  Istituto Auxologico Italiano

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: April 8, 2020
• Primary Completion: July 10, 2020
• Study Completion: September 10, 2021
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be available for individual participant data meta-analysis

Locations

IT (1)