COVID-19, SARS-CoV-2
Conditions
Keywords
SARS-CoV-2, COVID-19, cancer, IgM-IgG, seroprevalence
Brief summary
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.
Detailed description
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).
Interventions
OTHERserological test
serological test assessing IgM and IgG directed against SARS-CoV-2
OTHERRapid molecular test
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
GENETICNext generation Sequencing (NGS) analysis
analysis of genetic variability of virus and host
OTHERserum chemistry analysis
Analysis of serum chemistry factors and coagulation panel in blood samples
Sponsors
AUSL Romagna
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For epidemiologic analysis: Inclusion Criteria: * Age \> 18 years * asymptomatic * One of the following three conditions: • Healthy subjects who have had contact with COVID-19 positive patients • Healthcare workers • oncological patients candidates for cytotoxic chemotherapy at myeloablative doses (such as transplants) or treated with immune-check point inhibitors. * informed consent to the study and processing of data
Exclusion criteria
* presence of symptoms for COronaVIrus Disease 19 (COVID-19) (fever \> 37.5 °, cough, shortness of breath) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| epidemiology | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation | 12 months | IgG and IgM antibodies evaluation over time |
| methods comparison | 24 months | Make a comparison between different serological investigation methods and rapid molecular methods becoming available |
| correlation between biochemical and coagulative factors with SARS-CoV-2 positivity. | 24 months | To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity |
| phylogenetic map | 24 months | Building a phylogenetic map of an epidemic Italian macro-region |
| interactions between the virus and host cells | 24 months | Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19 |
Countries
Italy
Contacts
Primary ContactGiovanni Martinelli, Prof
Backup ContactOriana Nanni, Dr
Outcome results
None listed