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NCT04712448: SPARE
Serum Prevalence of SARS-Cov-2 Antibodies in Pre-pandemic Blood Samples (SPARE)
trial testing Anti-COVID test in Healthy in 3,500 participants. Participants enrolled and being followed up; not accepting new ones.
18 October 2023
Quick facts
| Lead sponsor | IRCCS San Raffaele Roma |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 3,500 |
| Start date | 30 December 2020 |
| Primary completion | 18 October 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Anti-COVID test
Conditions studied
- Healthy — all drugs for Healthy →
- Chronic Disease — all drugs for Chronic Disease →
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.
Verify or expand the search:
- PubMed search for NCT04712448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04712448 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele Roma
- Last refreshed: 10 April 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing