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

Completed

• Conditions: Kidney Transplant; Pancreatic Transplat; Pancreatic Islets Langerhans
• Interventions: Procedure: blood sample for seroepidemiological investigation

• Registration Number: NCT04487197
• Lead Sponsor: Antonio Secchi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-27
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	blood sample for seroepidemiological investigation	* 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.
Cohort 1	blood sample for seroepidemiological investigation	* Adult patients (age ≥ 18 years), * kidney or pancreas or pancreatic islets transplantation * transplanted patients (period: 01.01.2020 to 30.06.2020)

Primary Outcome Measures

Name	Time	Method
Serum-prevalence of COVID-19 TX	From 15 July 2020 to 15 January 2021	Evaluation 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 patients	From 15 July 2020 to 15 January 2021	Correlation serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy