Observational Study Concerning COVID-19 Infection in Transplanted Kidney, Pancreas or Pancreatic Islet Patients

June 19, 2020 updated by: Antonio Secchi, IRCCS San Raffaele

Observational Study to Assess the Health Status of Transplanted Patients (Kidney or Pancreas or Pancreatic Islet Transplantation) at Transplant Medicine Unit (MITRA) During the COVID-19 Pandemic

Collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the COVID-19 pandemic. All informations will be collected by short questionnaire via phone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

644

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
      • Milano, 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 to 90 years (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:

Transplanted Kidney or Kidney/Pancreas or Pancreas or Pancreatic Islet patients at Transplant Medicine Unit - San Raffaele Scientif Institute

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
Transplanted patients
Transplanted Kidney, Pancreas or Pancreatic Islet patients at MedicineTransplant Unit - San Raffaele Scientific Istitute
Other: Practice details
Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Prevalence of COVID-19 TX
Time Frame: From 01st February 2020 to 18 May 2020
Global Prevalence of COVD-19 infection in transplanted patients
From 01st February 2020 to 18 May 2020
Hospitalization rate in COVID-19 TX
Time Frame: From 01st February 2020 to 18 May 2020
Hospitalization rate of transplanted patients
From 01st February 2020 to 18 May 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation COVID-19 TX and type of transplantation
Time Frame: From 01st February 2020 to 18 May 2020
Correlation between type of transplantation to COVID-19 virus infection
From 01st February 2020 to 18 May 2020
Prevalence of COVID-19 TX in italian provinces
Time Frame: From 01st February 2020 to 18 May 2020
Prevalence COVID-19 virus infection in transplanted patients in italian provinces
From 01st February 2020 to 18 May 2020
Symptoms in COVID-19 TX
Time Frame: From 01st February 2020 to 18 May 2020
Prevalence of different symptoms in COVID-19 virus infection in transplanted patients
From 01st February 2020 to 18 May 2020
Correlation COVID-19 TX and comorbidities
Time Frame: From 01st February 2020 to 18 May 2020
Correlation between comorbidities to COVID-19 virus infection
From 01st February 2020 to 18 May 2020
COVID-19 TX Therapies
Time Frame: From 01st February 2020 to 18 May 2020
Impact of different therapies on COVID-19 virus infection in transplanted patients
From 01st February 2020 to 18 May 2020
COVID-19 TX in family settings
Time Frame: From 01st February 2020 to 18 May 2020
Impact of COVID-19 virus infection in transplanted patients family settings
From 01st February 2020 to 18 May 2020

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Antonio Secchi, IRCCS San Raffaele

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)

May 4, 2020

Primary Completion (Actual)

May 18, 2020

Study Completion (Actual)

May 18, 2020

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 MITRA

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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