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

February 9, 2021 updated by: Antonio Secchi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Transplanted Kidney, Pancreas or Pancreatic Islet patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
  • 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
blood sample for seroepidemiological investigation
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.
Procedure: blood sample for seroepidemiological investigation
blood sample for seroepidemiological investigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum-prevalence of COVID-19 TX
Time Frame: From 15 July 2020 to 15 January 2021
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
Time Frame: 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
From 15 July 2020 to 15 January 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asymptomatic or subclinical infections in transplanted patients
Time Frame: From 15 July 2020 to 15 January 2021
Determine % Asymptomatic or subclinical infections in transplanted patients
From 15 July 2020 to 15 January 2021
Risk factors for infection COVID-19 transplanted patients
Time Frame: From 15 July 2020 to 15 January 2021
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
Time Frame: From 15 July 2020 to 15 January 2021
Evaluate hospitalization rate in transplanted patients
From 15 July 2020 to 15 January 2021
Mortality rate COVID-19 transplanted patients
Time Frame: From 15 July 2020 to 15 January 2021
Evaluate mortality rate in transplanted patients
From 15 July 2020 to 15 January 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonio Secchi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-SIERO TRAPIANTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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