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

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

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

Conditions
-----------------
Kidney Transplant, Pancreatic Transplat, Pancreatic Islets Langerhans

Intervention / Treatment
-----------------
* Procedure: blood sample for seroepidemiological investigation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Adult patients (age ≥ 18 years), kidney or pancreas or pancreatic islets transplantation transplanted patients (period: 01.01.2020 to 30.06.2020) | Procedure: blood sample for seroepidemiological investigation<br>* blood sample for seroepidemiological investigation<br>|
| Cohort 2<br>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. | Procedure: blood sample for seroepidemiological investigation<br>* blood sample for seroepidemiological investigation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum-prevalence of COVID-19 TX | Evaluation of serum-prevalence data transplanted patients (symptomatic vs asymptomatic patients) | From 15 July 2020 to 15 January 2021 | 
| Serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients | Correlation serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients | From 15 July 2020 to 15 January 2021 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 infection, Transplanted patients, kidney transplants, pancreas transplants, pancreatic islet transplantation