Serum Prevalence of SARS-Cov-2 Antibodies in Pre-pandemic Blood Samples (SPARE)

NCT04712448 | Active Not Recruiting

• 1 other identifier: 20/33
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Seroprevalence of antibodies anti-COVID-19

  Seroprevalence of antibodies anti-COVID-19

  May-October 2019

Secondary Outcomes (1)

• Correlation with blood group

  May-October 2019

Other Outcomes (1)

• Correlation with co-morbidities

  May-October 2019

Study Arms (2)

Healthy subjects

Donors of the Transfusion Center of Venice Healthy volunteers afferent to BioBIM

Diagnostic Test: Anti-COVID test

Patients

Patients with chronic diseases afferent to BioBIM

Diagnostic Test: Anti-COVID test

Interventions

Anti-COVID test DIAGNOSTIC_TEST

No intervention is foreseen by the protocol

Healthy subjects; Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study protocol will involve a total of 3500 subjects (3000 healthy subjects and 1000 patients with chronic diseases) aged\> 18 years, of both sexes. The two groups will be formed as follows: A- Healthy subjects among periodic blood donors of the Transfusion Center and volunteer donors of BioBIM B- Patients with chronic diseases including cardiovascular, respiratory, oncological and neurodegenerative diseases related to BioBIM

You may qualify if:

• Both sexes
• Age \>18 years
• Signed informed consent for the donation / sample storage in the Biological Bank

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Department of Transfusion Medicine Venice Area: collaborator
• Istituto per lo Studio, la Prevenzione e la Rete Oncologica: collaborator

Study Sites (1)

IRCCS San Raffaele

Rome, 00166, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and whole blood samples

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: December 30, 2020
• Primary Completion: October 18, 2023
• Study Completion: December 30, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

IT (1)