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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377776
Recruitment Status : Completed
First Posted : May 6, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Secchi, IRCCS San Raffaele

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Transplant Pancreas Tranplant Pancreatic Islet Transplantation Other: Practice details

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Study Type : Observational
Actual Enrollment : 644 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : May 4, 2020
Actual Primary Completion Date : May 18, 2020
Actual Study Completion Date : May 18, 2020

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




Primary Outcome Measures :
  1. 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

  2. Hospitalization rate in COVID-19 TX [ Time Frame: From 01st February 2020 to 18 May 2020 ]
    Hospitalization rate of transplanted patients


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Correlation COVID-19 TX and comorbidities [ Time Frame: From 01st February 2020 to 18 May 2020 ]
    Correlation between comorbidities to COVID-19 virus infection

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Transplanted Kidney, Pancreas or Pancreatic Islet patients
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377776


Locations
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Italy
IRCCS San Raffaele
Milano, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Antonio Secchi IRCCS San Raffaele
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Responsible Party: Antonio Secchi, Medicine Transplant Unit Director, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04377776    
Other Study ID Numbers: COVID-19 MITRA
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Secchi, IRCCS San Raffaele:
COVID-19 infection
Transplanted patients
kidney transplant
pancreas transplant
pancreatic islet transplantation