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

NCT04712448 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2024-04-10

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Anti-COVID test

No intervention is foreseen by the protocol

Sponsors & Collaborators

  • Department of Transfusion Medicine Venice Area

    collaborator UNKNOWN

  • Istituto per lo Studio, la Prevenzione e la Rete Oncologica

    collaborator OTHER

  • IRCCS San Raffaele Roma

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2023-10-18
Completion
2024-12-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712448 on ClinicalTrials.gov