Kidney TransplantNCT04377776
Observational Study Concerning COVID-19 Infection in Transplanted Kidney, Pancreas or Pancreatic Islet Patients
An observational study of Kidney Transplant and Pancreas Tranplant, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the COVID-19 pandemic. All informations will be collected by short questionnaire via phone. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Transplant, Pancreas Tranplant, Pancreatic Islet Transplantation
- What is being tested?
- Practice details
- How many people
- 644 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2020to 18 May 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Transplanted Kidney, Pancreas or Pancreatic Islet patients
Who may be able to join
- Transplanted Kidney or Kidney/Pancreas or Pancreas or Pancreatic Islet patients at Transplant Medicine Unit - San Raffaele Scientif Institute
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Assess the Health Status of Transplanted Patients (Kidney or Pancreas or Pancreatic Islet Transplantation) at Transplant Medicine Unit (MITRA) During the COVID-19 Pandemic
Collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the COVID-19 pandemic. All informations will be collected by short questionnaire via phone.
- Being tested
- Practice details
- Keywords
- COVID-19 infection, Transplanted patients, kidney transplant, pancreas transplant, 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.
Practice detailsOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Transplanted patients | Transplanted Kidney, Pancreas or Pancreatic Islet patients at MedicineTransplant Unit - San Raffaele Scientific Istitute Receives: Other: Practice details |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Prevalence of COVID-19 TX
Global Prevalence of COVD-19 infection in transplanted patients
Measured: From 01st February 2020 to 18 May 2020
Hospitalization rate in COVID-19 TX
Hospitalization rate of transplanted patients
Measured: From 01st February 2020 to 18 May 2020
Secondary outcomes (6)
Correlation COVID-19 TX and type of transplantation
Correlation between type of transplantation to COVID-19 virus infection
Measured: From 01st February 2020 to 18 May 2020
Prevalence of COVID-19 TX in italian provinces
Prevalence COVID-19 virus infection in transplanted patients in italian provinces
Measured: From 01st February 2020 to 18 May 2020
Symptoms in COVID-19 TX
Prevalence of different symptoms in COVID-19 virus infection in transplanted patients
Measured: From 01st February 2020 to 18 May 2020
Correlation COVID-19 TX and comorbidities
Correlation between comorbidities to COVID-19 virus infection
Measured: From 01st February 2020 to 18 May 2020
COVID-19 TX Therapies
Impact of different therapies on COVID-19 virus infection in transplanted patients
Measured: From 01st February 2020 to 18 May 2020
COVID-19 TX in family settings
Impact of COVID-19 virus infection in transplanted patients family settings
Measured: From 01st February 2020 to 18 May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start4 May 2020
- Primary completion18 May 2020
- Study completion18 May 2020
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.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Secchi, IRCCS San Raffaele
- Investigators
- Antonio Secchi, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377776
- Sponsor's protocol ID
- COVID-19 MITRA
- Status last verified
- Jun 2020
- First submitted
- 5 May 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess the Health Status of Transplanted Patients (Kidney or Pancreas or Pancreatic Islet Transplantation) at Transplant Medicine Unit (MITRA) During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04377776
- Acronym / sponsor ID
- COVID-19 MITRA
- Keywords
- COVID-19 infection, Transplanted patients, kidney transplant, pancreas transplant, pancreatic islet transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 6 May 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.
Collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the COVID-19 pandemic. All informations will be collected by short questionnaire via phone.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplanted patients | – | Other: Practice detailsTransplanted Kidney, Pancreas or Pancreatic Islet patients at MedicineTransplant Unit - San Raffaele Scientific Istitute |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transplanted Kidney, Pancreas or Pancreatic Islet patients
Key inclusion criteria (1 listed)
- Transplanted Kidney or Kidney/Pancreas or Pancreas or Pancreatic Islet patients at Transplant Medicine Unit - San Raffaele Scientif Institute
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Practice detailsQuestionnaire | Other | Transplanted patients |
Primary outcome
Global Prevalence of COVID-19 TX
Time frame: From 01st February 2020 to 18 May 2020
Global Prevalence of COVD-19 infection in transplanted patients
Hospitalization rate in COVID-19 TX
Time frame: From 01st February 2020 to 18 May 2020
Hospitalization rate of transplanted patients
6 secondary outcomes
Correlation COVID-19 TX and type of transplantation
Time frame: From 01st February 2020 to 18 May 2020
Prevalence of COVID-19 TX in italian provinces
Time frame: From 01st February 2020 to 18 May 2020
Symptoms in COVID-19 TX
Time frame: From 01st February 2020 to 18 May 2020
Correlation COVID-19 TX and comorbidities
Time frame: From 01st February 2020 to 18 May 2020
COVID-19 TX Therapies
Time frame: From 01st February 2020 to 18 May 2020
COVID-19 TX in family settings
Time frame: From 01st February 2020 to 18 May 2020
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 22 Jun 2020.
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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.
Antonio Secchi principal investigator
IRCCS San Raffaele
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 Pancreas Tranplant, run by IRCCS San Raffaele 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 1 inclusion and 0 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 22 Jun 2020. 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?
Global Prevalence of COVID-19 TX (time frame: From 01st February 2020 to 18 May 2020). 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 22 Jun 2020.