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SARS-CoV2 (COVID-19) Seroepidemiological Transplanted Subjects (Kidney, Kidney-pancreas, Pancreas, Langerhans Islets)

SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated Pancreas, Langerhans Islets

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04487197
Enrollment
282
Registered
2020-07-27
Start date
2020-07-15
Completion date
2021-01-15
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant, Pancreatic Islets Langerhans, Pancreatic Transplat

Keywords

COVID-19 infection, Transplanted patients, kidney transplants, pancreas transplants, pancreatic islet transplantation

Brief summary

Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted population using the Luciferase Immuno Precipitation System (LIPS) test.

Interventions

PROCEDUREblood sample for seroepidemiological investigation

blood sample for seroepidemiological investigation

Sponsors

Antonio Secchi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cohort 1: * Adult patients (age ≥ 18 years), * Kidney or pancreas or pancreatic islets transplantation * Transplanted patients (period: 01.01.2020 to 30.06.2020) * Informed Consent signed Inclusion Criteria Cohort 2: * Adult patients (age ≥ 18 years), * Kidney or pancreas or pancreatic islets transplantation * transplanted patients in follow-up since 01.01.2020 or trasplanted patients after 30.06.2020. * Informed Consent signed

Exclusion criteria

both Cohort (1&2): Symptomatology such as fever\> 37.5, and / or cough and / or respiratory distress and / or diarrhea / vomiting in 14 days prior to collection of blood sample

Design outcomes

Primary

MeasureTime frameDescription
Serum-prevalence of COVID-19 TXFrom 15 July 2020 to 15 January 2021Evaluation of serum-prevalence data transplanted patients (symptomatic vs asymptomatic patients)
Serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patientsFrom 15 July 2020 to 15 January 2021Correlation serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients

Secondary

MeasureTime frameDescription
Mortality rate COVID-19 transplanted patientsFrom 15 July 2020 to 15 January 2021Evaluate mortality rate in transplanted patients
Asymptomatic or subclinical infections in transplanted patientsFrom 15 July 2020 to 15 January 2021Determine % Asymptomatic or subclinical infections in transplanted patients
Risk factors for infection COVID-19 transplanted patientsFrom 15 July 2020 to 15 January 2021Determine risk factors for infection COVID-19 (comparison symtomatic and asymtomatic transplanted patients)
Hospitalization rate COVID-19 transplanted patientsFrom 15 July 2020 to 15 January 2021Evaluate hospitalization rate in transplanted patients

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026