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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487197
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Secchi, IRCCS San Raffaele

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

Condition or disease Intervention/treatment
Kidney Transplant Pancreatic Transplat Pancreatic Islets Langerhans Procedure: blood sample for seroepidemiological investigation

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated Pancreas, Langerhans Islets
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

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




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Hospitalization rate COVID-19 transplanted patients [ Time Frame: From 15 July 2020 to 15 January 2021 ]
    Evaluate hospitalization rate in transplanted patients

  4. Mortality rate COVID-19 transplanted patients [ Time Frame: From 15 July 2020 to 15 January 2021 ]
    Evaluate mortality rate in transplanted patients



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Ages Eligible for Study:   18 Years and older   (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 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


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): NCT04487197


Contacts
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Contact: Rossana Caldara +390226432121 caldara.rossana@hsr.it
Contact: Federica Pazzi pazzi.federica@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Paola Maffi    +390226433705    maffi.paola@hsr.it   
Sponsors and Collaborators
Antonio Secchi
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Responsible Party: Antonio Secchi, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04487197    
Other Study ID Numbers: COVID-SIERO TRAPIANTI
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 transplants
pancreas transplants
pancreatic islet transplantation