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OpenTrials
Completed

NCT Number: NCT04487197

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

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

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Key information

Conditions

Kidney Transplant COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pancreatic Islets Langerhans Pancreatic Transplat Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample for seroepidemiological investigation

Procedure

blood sample for seroepidemiological investigation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Antonio Secchi

Other

Registry information

Official study title

SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated Pancreas, Langerhans Islets

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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