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

NCT04371289 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4356

Last updated 2024-02-20

No results posted yet for this study

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. Enroll around 5500 COVID-19 patients (1000 outpatients and 4500 in-patients), which will allow to:

1.1 Phenotype patients with COVID-19 of variable severity 1.2 Assess the prevalence of COVID-19 among GPs in relation with their use of PPE 1.3 Evaluate the impact of patients' demographic and clinical characteristics COVID-19 severity
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. 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

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Gianfranco Parati, MD, PhD · Istituto Auxologico Italiano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2020-07-10
Completion
2021-09-10

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04371289 on ClinicalTrials.gov