This is an observational study. The aim is to describe the natural history and clinicalevolution over time of hospitalized patients affected by Severe Acute RespiratorySyndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of thedisease and improve therapeutic procedures.
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:
1. 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;
2. 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:
1. 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;
2. 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;
3. 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;
4. 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;
5. 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).
Other: Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.
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.
Inclusion Criteria:
1. Clinical and / or radiological diagnosis of lung infection with COVID-19;
2. Positive test for SARS-CoV-2 infection.
Exclusion Criteria:
1. Age less than 18 years
ASST Monza-Ospedale San Gerardo
Monza, Italy
Investigator: Paolo Bonfanti
Paolo Bonfanti
+39 039 233 9310
paolo.bonfanti@unimib.it