SARS-CoV2 (COVID-19) Seroepidemiological Transplanted Subjects (Kidney, Kidney-pancreas, Pancreas, Langerhans Islets)
1 other identifier
observational
282
1 country
1
Brief Summary
Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted population using the Luciferase Immuno Precipitation System (LIPS) test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2020
CompletedFirst Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedFebruary 10, 2021
February 1, 2021
6 months
July 24, 2020
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum-prevalence of COVID-19 TX
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
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 Outcomes (4)
Asymptomatic or subclinical infections in transplanted patients
From 15 July 2020 to 15 January 2021
Risk factors for infection COVID-19 transplanted patients
From 15 July 2020 to 15 January 2021
Hospitalization rate COVID-19 transplanted patients
From 15 July 2020 to 15 January 2021
Mortality rate COVID-19 transplanted patients
From 15 July 2020 to 15 January 2021
Study Arms (2)
Cohort 1
* Adult patients (age ≥ 18 years), * kidney or pancreas or pancreatic islets transplantation * transplanted patients (period: 01.01.2020 to 30.06.2020)
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.
Interventions
blood sample for seroepidemiological investigation
Eligibility Criteria
Transplanted Kidney, Pancreas or Pancreatic Islet patients
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Antonio Secchilead
Study Sites (1)
IRCCS San Raffaele
Milan, 20132, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 24, 2020
First Posted
July 27, 2020
Study Start
July 15, 2020
Primary Completion
January 15, 2021
Study Completion
January 15, 2021
Last Updated
February 10, 2021
Record last verified: 2021-02