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

Sponsor
Antonio Secchi (Other)
Overall Status
Completed
CT.gov ID
NCT04487197
Collaborator
(none)
282
Enrollment
1
Location
6
Actual Duration (Months)
46.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: blood sample for seroepidemiological investigation

Study Design

Study Type:
Observational
Actual Enrollment :
282 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 :
Jul 15, 2020
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Jan 15, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Serum-prevalence of COVID-19 TX [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 [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 [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 [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 [From 15 July 2020 to 15 January 2021]

    Evaluate hospitalization rate in transplanted patients

  4. Mortality rate COVID-19 transplanted patients [From 15 July 2020 to 15 January 2021]

    Evaluate mortality rate in transplanted patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • Antonio Secchi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Secchi, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT04487197
Other Study ID Numbers:
  • COVID-SIERO TRAPIANTI
First Posted:
Jul 27, 2020
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antonio Secchi, MD, IRCCS San Raffaele
COVID-19 infection
Transplanted patients
kidney transplants
pancreas transplants
pancreatic islet transplantation
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Feb 10, 2021