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NCT04712448: SPARE

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

Active, enrolled Last updated 10 April 2024
What this trial tests

trial testing Anti-COVID test in Healthy in 3,500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
30 December 2020
Primary endpoint
18 October 2023
30 December 2024

Quick facts

Lead sponsorIRCCS San Raffaele Roma
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment3,500
Start date30 December 2020
Primary completion18 October 2023
Estimated completion30 December 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

IRCCS San Raffaele Roma — full company profile →

Who can join

Adults 18 to 80, any sex, with Healthy or Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04712448.

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