CompletedNot Applicable

ANTI-SARS-CoV-2 SEROCONVERSIO IN IMMUNE-MEDIATED KIDNEY DISEASES

Italy120 participantsStarted 2022-09-09

Plain-language summary

This is a multicentric, observational, retrospective study. The primary endpoint of the study is to investigate the humoral immunological response to SARS-Cov-2 vaccination in this population, looking for clinical features predisposing to seroconversion failure. Secondary endpoints are * to investigate the appearance of symptomatic SARS-CoV-2 infection, despite vaccination, looking for any clinical features predisposing to infection, * to identify the protective cut-off of antibody titer against SARS-CoV-2 infection. Each study participating center will select all vaccinated patients with immune-mediated renal diseases for whom anti-COVID serology will be available.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1.Age ≥ 18 years 2. MRI diagnosis (biopsy and non-biopsy) 3. At least one complete vaccination cycle according to the indications of the NHS (consisting of two doses or a single dose depending on the type of vaccine) 4. Signing of informed consent 5. At least one dose of anti-SARS-CoV2 IgG antibodies performed after a complete vaccination course Exclusion Criteria: * SARS-CoV-2 infection, before or during the vaccination cycle (between I and II dose), diagnosed by molecular swab or positivity to anti-Nucleocapsid antibodies or anti-Spike IgM.

What they're measuring

Seroconversion for antiSARS-CoV-2 antibodies

Timeframe: 12 months from first vaccination

Trial details

NCT IDNCT06753942

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

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