Kidney TransplantNCT04487197
SARS-CoV2 (COVID-19) Seroepidemiological Transplanted Subjects (Kidney, Kidney-pancreas, Pancreas, Langerhans Islets)
An observational study of Kidney Transplant and Pancreatic Transplat, run by Antonio Secchi at 1 site in Italy.
Trial summary
Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted population using the Luciferase Immuno Precipitation System (LIPS) test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Pancreatic Transplat, Pancreatic Islets Langerhans
- What is being tested?
- blood sample for seroepidemiological investigation
- Type of treatment
- Surgery or procedure
- How many people
- 282 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Transplanted Kidney, Pancreas or Pancreatic Islet patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated 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.
- Being tested
- blood sample for seroepidemiological investigation
- Keywords
- COVID-19 infection, Transplanted patients, kidney transplants, pancreas transplants, pancreatic islet transplantation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample for seroepidemiological investigationProcedure or surgery
blood sample for seroepidemiological investigation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | * Adult patients (age ≥ 18 years),
* kidney or pancreas or pancreatic islets transplantation
* transplanted patients (period: 01.01.2020 to 30.06.2020) Receives: Procedure: 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. Receives: Procedure: blood sample for seroepidemiological investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum-prevalence of COVID-19 TX
Evaluation of serum-prevalence data transplanted patients (symptomatic vs asymptomatic patients)
Measured: 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
Measured: From 15 July 2020 to 15 January 2021
Secondary outcomes (4)
Asymptomatic or subclinical infections in transplanted patients
Determine % Asymptomatic or subclinical infections in transplanted patients
Measured: From 15 July 2020 to 15 January 2021
Risk factors for infection COVID-19 transplanted patients
Determine risk factors for infection COVID-19 (comparison symtomatic and asymtomatic transplanted patients)
Measured: From 15 July 2020 to 15 January 2021
Hospitalization rate COVID-19 transplanted patients
Evaluate hospitalization rate in transplanted patients
Measured: From 15 July 2020 to 15 January 2021
Mortality rate COVID-19 transplanted patients
Evaluate mortality rate in transplanted patients
Measured: From 15 July 2020 to 15 January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Secchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Secchi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487197
- Sponsor's protocol ID
- COVID-SIERO TRAPIANTI
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated Pancreas, Langerhans Islets
- ClinicalTrials.gov ID
- NCT04487197
- Acronym / sponsor ID
- COVID-SIERO TRAPIANTI
- Keywords
- COVID-19 infection, Transplanted patients, kidney transplants, pancreas transplants, pancreatic islet transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Antonio SecchiUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted population using the Luciferase Immuno Precipitation System (LIPS) test.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: blood sample for seroepidemiological investigation* Adult patients (age ≥ 18 years), * kidney or pancreas or pancreatic islets transplantation * transplanted patients (period: 01.01.2020 to 30.06.2020) |
| Cohort 2 | – | Procedure: blood sample for seroepidemiological investigation* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transplanted Kidney, Pancreas or Pancreatic Islet patients
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample for seroepidemiological investigationblood sample for seroepidemiological investigation | Procedure or surgery | Cohort 1, Cohort 2 |
Primary outcome
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)
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
4 secondary outcomes
Asymptomatic or subclinical infections in transplanted patients
Time frame: From 15 July 2020 to 15 January 2021
Risk factors for infection COVID-19 transplanted patients
Time frame: From 15 July 2020 to 15 January 2021
Hospitalization rate COVID-19 transplanted patients
Time frame: From 15 July 2020 to 15 January 2021
Mortality rate COVID-19 transplanted patients
Time frame: From 15 July 2020 to 15 January 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant and Pancreatic Transplat, run by Antonio Secchi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum-prevalence of COVID-19 TX (time frame: From 15 July 2020 to 15 January 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.