The Natural History of Hospitalized COVID-19 Patients

Study Overview
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Brief Summary
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This is an observational study. The aim is to describe the natural history and clinical evolution over time of hospitalized patients affected by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of the disease and improve therapeutic procedures.

Detailed Description
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BACKGROUND: As of the end of February 2020, the ASST of Monza, with its two hospital wards of Monza and Desio, has treated 1433 COVID+ patients, of which 507 have currently been discharged (35.4%) and 206 (14%) transferred to other Low-intensity care facilities. The importance of observational studies is now known in many fields of medicine and the real life data produced have become an integral part of the authorization dossiers by the competent authorities to govern the introduction of new drugs: in particular, in a disease such as that from COVID-19 in which the absence of specific anti-viral therapies prevents an ad hoc cure, it becomes fundamental to identify and validate systems of stratification of the risk of fatal events, in order to optimize health intervention measures. METHODS AND STUDY DESIGN: The study protocol provides the collection of clinical, diagnostic and therapeutic and laboratory data consistent with the objectives of the study (CORE DATA SET) to which other specific protocols and relative data will connect (DATABASE leaf). The data collection will be performed on eCRF (RedCap platform) and the database will have the stem and leaf structure, compatible with WHO indications regarding pandemic data collection. CORE DATA SET: The protocol presents two important aspects of innovation in its formulation and design: The stem and leaf structure will allow to collect all the core data of the study (stem) capable of describing the primary objective, that is the natural history of the disease, thus providing an important contribution to knowledge, currently very scarce , the evolution of the disease; the extreme heterogeneity of the pathology itself, the methods of spreading the contagion and the problematic treatment of some particular patient populations, however impose the description and the potential validation, not only in the context of subgroup analyzes, but in studies dedicated, of the data collected The stem and leaf design could therefore answer both questions. BIOLOGICAL SAMPLE COLLECTION: The biological research areas that the protocol proposes to pursue are listed below: Study of genetic determinants of COVID-19 infection with the aim of identifying the bases of the different susceptibility in relation to age, sex and presence of co-morbidity; Study of the repertoire of B and T lymphocyte receptors and identification of the virus-specific sequences of the T receptor for the antigen with the aim of identifying the component of the viral genome relevant to the immune response with possible relapses for the development of a vaccine; Study of the activation of the inflammosome responsible for the abnormal and severe inflammatory response characteristic of patients with COVID-19 infection and serious lung complications with the aim of identifying possible specific targets of intervention against one or more inflammatory cytokines; Study of the serological response during the acute phase of the disease and convalescence with the aim of defining the possible state of protection from the disease itself; Study of the proteome with the aim of defining biomarkers capable of evaluate the risk of progression. STATISTICAL ANALYSIS: For each specific protocol, the study design and statistical data analysis plan will be formulated according to the specific objectives. In general, in addition to the descriptive methods, statistical regression models and methods for the definition of prognostic scores will be used, with relative cross-validation, which will allow to evaluate both binary and survival outcomes (in a broad sense, of events considered in time).

Official Title
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Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial

Conditions
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Sars-CoV2

Intervention / Treatment
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* Other: Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and / or radiological diagnosis of lung infection with COVID-19; Positive test for SARS-CoV-2 infection. Exclusion Criteria: 1. Age less than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid19 infection related patients<br>The patients enrolled in the study are all patients with clinical and microbiological diagnosis of COVID-19 infection hospitalized since February 23, 2020 at San Gerardo Hospital (ASST-Monza). | Other: Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.<br>* Describe the natural history and clinical evolution of hospitalized patients over time affected by SARS-COV-2 infection, understand the pathogenesis of the disease and improve the aids and therapeutic procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covid19 infection clinical evolution | Description over time of hospitalized patients suffering from SARS-COV-2 infection to better understand the pathogenesis of the disease and improve the controls and therapeutic procedures. | Until patient discharge from the hospital (approximately 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for intra-hospital mortality | Identify risk factors for intra-hospital mortality in hospital wards COVID + patients. | Until patient discharge from the hospital (approximately 1 year) | 
| The impact of a fragility index (IF) | Assess the impact of a fragility index (IF) on the clinical course of COVID + patients. | Until patient discharge from the hospital (approximately 1 year) | 
| Prognostic score | Build a prognostic score through which it is possible define a stratification that orients, according to the state of hospitalization, the therapeutic choices. | Until patient discharge from the hospital (approximately 1 year). | 
| The lung sequelae of SARS-COV-2 pneumonia | Differentiate the lung sequelae related to the evolution of viral damage from those of cheater / volutrauma connected to non-invasive (NIV-CPAP) or invasive (MV) ventilation methods. | Until patient discharge from the hospital (approximately 1 year) | 
| The accuracy of IF in elderly patients | Assess the accuracy of IF in elderly patients in terms of clinical outcomes compared to one clinical evaluation based on age and co-morbidity. | Until patient discharge from the hospital (approximately 1 year) | 
| Coagulation system anomalies | Describe the anomalies of the coagulation system, which appear on patients affected by SARS-COV-2 pneumonia. | Until patient discharge from the hospital (approximately 1 year) | 
| The impact of the prone position on the oxygenation | Description of the impact of the prone position in terms of increased oxygenation of the patient suffering from SARS-COV-2 pneumonia as an index lung recruitment. | Until patient discharge from the hospital (approximately 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sars-covid-2, coronavirus infection, Coronavirus