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| Name | Class |
|---|---|
| AUSL Romagna | UNKNOWN |
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Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics.
The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.
The outbreak of COVID-19 infections is spreading in Italy with unprecedented severity characteristics. In this context, it is essential to collect data relating to the epidemiology of the disease, to outline further useful tools for diagnosis and to define the correct use of rapid molecular and / or serological tests in the surveillance of high-risk subjects (cancer patients and healthcare operators), in order to identify any new disease control strategies, crucial to reduce the transmission and to outline specific guidelines for cancer patients healthcare management. It is also necessary to identify the factors that determine the evolution of the viral genome over time in the various geographical areas and also the potential susceptibility markers in the different types of affected subjects (symptomatic, mildly symptomatic and asymptomatic).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| asymptomatic population at high risk of infection | healthy individuals at high risk of infection, including individuals who have had contact with a patient tested positive for COVID-19, voluntary health workers and oncological patients candidate to immunosuppressive therapy |
| |
| COVID-19 patients | patients with confirmed diagnosis of COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serological test | Other | serological test assessing IgM and IgG directed against SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| epidemiology | Investigate the epidemiology of the infection in an asymptomatic population including both healthy individuals at high risk of infection and oncological patients by assessing the seroprevalence of IgG and IgM antibodies against the SARS-CoV-2 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation | IgG and IgM antibodies evaluation over time | 12 months |
| methods comparison | Make a comparison between different serological investigation methods and rapid molecular methods becoming available |
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For epidemiologic analysis:
Inclusion Criteria:
Exclusion Criteria:
For analysis of viral/host genetic factors involved in susceptibility/resistance to infection, samples from patients with confirmed diagnosis of COVID-19, residual from diagnostic procedures will be analyzed. All samples for genetic analysis will be anonymized.
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For epidemiologic analysis, asymptomatic population 350 health workers / healthy subjects at risk of infection and 50 cancer patients candidates for immunosuppressive therapies will be enrolled.
For analysis of genetic variability of virus and host factors impacting on susceptibility to infection: samples from about 100 SARS-CoV-2 positive patients (sintomatic, paucisintomatic or asymptomatic), retained at Pievesestina Laboratory after diagnostic procedure, will be analyzed. All samples for genetic analysis will be anonymized.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Martinelli, Prof | Contact | +39 0543 739100 | giovanni.martinelli@irst.emr.it | |
| Oriana Nanni, Dr | Contact | +39 0543 739100 | oriana.nanni@irst.emr.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Martinelli, Prof. | IRST IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna | Active, not recruiting | Cesena | FC | 47522 | Italy | |
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oropharyngeal and nasal swabs and blood samples will be collected
| Rapid molecular test | Other | Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab |
|
| Next generation Sequencing (NGS) analysis | Genetic | analysis of genetic variability of virus and host |
|
| serum chemistry analysis | Other | Analysis of serum chemistry factors and coagulation panel in blood samples |
|
| 24 months |
| correlation between biochemical and coagulative factors with SARS-CoV-2 positivity. | To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity | 24 months |
| phylogenetic map | Building a phylogenetic map of an epidemic Italian macro-region | 24 months |
| interactions between the virus and host cells | Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19 | 24 months |
| Irst Irccs |
| Recruiting |
| Meldola |
| FC |
| 47014 |
| Italy |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012698 | Serologic Tests |
| D059014 | High-Throughput Nucleotide Sequencing |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
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