Serum Prevalence of Antibodies Anti-SARS-Cov-2 in Healthy Subjects and in Patients With Chronic Diseases in Pre-pandemic Blood Samples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,500
- Locations
- 1
- Primary Endpoint
- Seroprevalence of antibodies anti-COVID-19
Study Overview
Brief Summary
The first reports of infections caused by SARS-CoV-2 were released from Wuhan, China in December 2019. From there, the infection quickly spread into a pandemic form. The clinical manifestation of the infection varies enormously, from totally asymptomatic or mildly symptomatic forms, with nonspecific and flu-like manifestations, to an acute respiratory distress syndrome which, in patients requiring hospitalization in the ICU and mechanical ventilation invasive, can lead to death, especially in elderly subjects and carriers of co-morbidities. Recently, the association of blood groups ABO as possible biological markers of susceptibility to COVID-19, has been evaluated, linking blood type O with a lower chance of infection, blood type A with the highest risk, and blood group B with the greatest complications.
In Italy, the first non "imported" case dates back to February 2020, although new evidence on subjects tested positive for the antibody assay on serum samples suggests that the virus started to circulate before the official date.
Few are the data relating to asymptomatic infections or with mild non-specific and nuanced symptoms that have been quantified in about 85% of the total number of infected. Moreover, thanks to the availability of serological tests that identify the presence of anti-SARS-CoV-2 antibodies, it emerged that a proportion of the population was infected by the virus and developed an antibody response and that almost 30% of the people with antibodies were asymptomatic. In order to evaluate the seroprevalence of COVID-19 infection among asymptomatic subjects the investigators will conduct specific serological tests (total antibodies) to identify the prevalence of SARS-2-CoV antibodies among healthy blood donors who went to transfusion facilities of the DIMT in Venice during the pandemic (about 2500 periodic donors who referred to the Transfusion Center in the period between May and October 2019). Patients afferent to the Interinstitutional Multidisciplinary Biobank (BioBIM) of the Research Center of the IRCCS San Raffaele Pisana in Rome, with or without concomitant co-morbidities (about 1000 subject) will be also tested. All samples will be analyzed for any association with sex, age group and blood group.
Detailed Description
- Title Serum prevalence of SARS-Cov-2 antibodies in pre-pandemic blood samples
- Background The first reports of infections caused by SARS-CoV-2, a Beta Corona virus, single-stranded RNA, were released from Wuhan, China in December 2019. From there, the infection quickly spread into a pandemic form.
The clinical manifestation of the infection varies enormously, from totally asymptomatic or mildly symptomatic forms, with nonspecific and flu-like manifestations, to an acute respiratory distress syndrome which, in patients requiring hospitalization in the ICU and mechanical ventilation invasive, can lead to death. The greater severity of the course of the infection depends greatly on the general conditions of the patients, being maximum in elderly subjects and carriers of co-morbidities. Recent studies have also evaluated the association of blood groups ABO as possible biological markers of susceptibility to COVID-19, suggesting that people with blood type O have a lower chance of infection while individuals with blood type A are most at risk, and people with blood group B have the greatest complications in the event of infection.
In Italy, the first non "imported" case dates back to February 2020 in a person residing in Lombardy, in the province of Lodi. However, new evidence on subjects tested positive for the antibody assay on serum samples suggests that the virus started to circulate before the official date.
Initially, due to the sudden explosion of cases, epidemiological surveillance focused on patients related to health facilities because they were symptomatic, suspicious and high-risk contacts. Few are the data relating to asymptomatic infections or with mild non-specific and nuanced symptoms that, data from China, would quantify in about 85% of the total number of infected. Precisely on the role of person-to-person transmission in the course of asymptomatic infection and in the subclinical phases of the disease, epidemiological data are lacking despite they could prove to be very important. In fact, thanks to the availability of serological tests that identify the presence of anti-SARS-CoV-2 antibodies, it emerged that a proportion of the population was infected by the virus and developed an antibody response and that almost 30% of the people with antibodies were asymptomatic. Therefore, the understanding of the prevalence of the disease and the prevalence of the antibody response appear to be of considerable interest, as it seems to be established that asymptomatic subjects can transmit the SARS-CoV-2 infection for a period that in some cases has proved greater than 14 days.
In order to evaluate the seroprevalence of COVID-19 infection among asymptomatic subjects, thus obtaining a real estimate of the beginning of the circulation of the virus in Italy, in the present study the investigators intend to conduct specific serological tests (total antibodies) to identify the prevalence of SARS-2-CoV antibodies among healthy blood donors who went to transfusion facilities of the DIMT in Venice during the pandemic (about 2500 periodic donors who referred to the Transfusion Center in the period between May and October 2019).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Both sexes
- •Age >18 years
- •Signed informed consent for the donation / sample storage in the Biological Bank
Exclusion Criteria
- •for healthy subjects: all those who have shown any symptoms, albeit mild, in the 28 days prior to the donation.
- •for patients: who have not signed the informed consent for the conservation of their samples in the Biological Bank.
Outcomes
Primary Outcomes
Seroprevalence of antibodies anti-COVID-19
Time Frame: May-October 2019
Seroprevalence of antibodies anti-COVID-19
Secondary Outcomes
- Correlation with blood group(May-October 2019)
