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
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
-
-
-
Milan, Italy, 20132
- IRCCS San Raffaele
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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
|
blood sample for seroepidemiological investigation
|
|
Cohort 2
|
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
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.