Clinical trial NCT04424992: The Natural History of Hospitalized COVID-19 Patients
Official title: Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Keywords: Coronavirus
sars-covid-2
coronavirus infection
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 1433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Covid19 infection clinical evolution
timeFrame: Until patient discharge from the hospital (approximately 1 year)
Secondary outcomes:
measure: Risk factors for intra-hospital mortality
timeFrame: Until patient discharge from the hospital (approximately 1 year)
measure: The impact of a fragility index (IF)
timeFrame: Until patient discharge from the hospital (approximately 1 year)
measure: Prognostic score
timeFrame: Until patient discharge from the hospital (approximately 1 year).
measure: The lung sequelae of SARS-COV-2 pneumonia
timeFrame: Until patient discharge from the hospital (approximately 1 year)
measure: The accuracy of IF in elderly patients
timeFrame: Until patient discharge from the hospital (approximately 1 year)
measure: Coagulation system anomalies
timeFrame: Until patient discharge from the hospital (approximately 1 year)
measure: The impact of the prone position on the oxygenation
timeFrame: Until patient discharge from the hospital (approximately 1 year)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST Monza-Ospedale San Gerardo
Study officials:
References:
citation: Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available.
citation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
citation: Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.
citation: Yuan FF, Tanner J, Chan PK, Biffin S, Dyer WB, Geczy AF, Tang JW, Hui DS, Sung JJ, Sullivan JS. Influence of FcgammaRIIA and MBL polymorphisms on severe acute respiratory syndrome. Tissue Antigens. 2005 Oct;66(4):291-6. doi: 10.1111/j.1399-0039.2005.00476.x.
citation: Coppadoro A, Benini A, Fruscio R, Verga L, Mazzola P, Bellelli G, Carbone M, Mulinacci G, Soria A, Noe B, Beck E, Di Sciacca R, Ippolito D, Citerio G, Valsecchi MG, Biondi A, Pesci A, Bonfanti P, Gaudesi D, Bellani G, Foti G. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak. Crit Care. 2021 Feb 24;25(1):80. doi: 10.1186/s13054-021-03502-y.