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NCT04487197 Clinical Trial

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

Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04487197
Other study ID # COVID-SIERO TRAPIANTI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date January 15, 2021

Study information
Verified date February 2021
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 282
Est. completion date January 15, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• blood sample for seroepidemiological investigation
blood sample for seroepidemiological investigation

Locations
Country Name City State
Italy IRCCS San Raffaele Milan

Sponsors (1)
Lead Sponsor Collaborator
Antonio Secchi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Asymptomatic or subclinical infections in transplanted patients Determine % Asymptomatic or subclinical infections in transplanted patients From 15 July 2020 to 15 January 2021
Secondary 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
Secondary Hospitalization rate COVID-19 transplanted patients Evaluate hospitalization rate in transplanted patients From 15 July 2020 to 15 January 2021
Secondary Mortality rate COVID-19 transplanted patients Evaluate mortality rate in transplanted patients From 15 July 2020 to 15 January 2021
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