Covid19NCT04694573
Multicenter CTS Pre-and Post-Transplantation Covid-19 Serum Studies
An observational study of Covid19 and Kidney Transplant; Complications, run by Heidelberg University at 1 site in Germany.
Trial summary
The Covid-19 Serum Study is a prospective case-control study in 1. kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study) or 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, Kidney Transplant; Complications, Kidney Transplant Failure and Rejection
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 28 Dec 2020to 28 Dec 2022
- How long will I take part?
- 5 Years
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney- or liver transplant recipients with a SARS-CoV-2 infection prior to transplantation (PRE-TX Covid-19 Serum Study) or a SARS-CoV-2 infection after transplantation (POST-TX Covid-19 Serum Study), 2 matched controls
Who may be able to join
- Kidney-transplant recipients and full-size liver-recipients (de-novo or re-transplanted)
- Participant or legal guardian is willing and able to give informed consent for participation in the trial
- SARS-CoV-2 infection before transplantation (PRE-TX Covid-19 Serum Study) or after transplantation (POST-TX Covid-19 Serum Study)
- Specific Inclusion Criteria for PRE-TX Covid-19 Serum Study:
- Kidney or liver transplantation between Dec 17,2020 - Dec 17, 2021
- Specific Inclusion Criteria for POST-TX Covid-19 Serum Study:
- Hospitalization due to SARS-CoV-2 infection in between Dec 17,2020 - Dec 17, 2021
Who cannot join
- Participants not meeting the inclusion criteria
- multi-organ transplant recipients
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Nierenzentrum Heidelberg
Heidelberg, DE, 69120
Christian Morath, Professor, +49 (0)6221-91120, christian.morath@med.uni-heidelberg.de
Louise Benning, Dr.med., louise.benning@med.uni-heidelberg.de
About this study
Official title: Collaborative Transplant Study (CTS) Pre- and Post-Transplantation Covid-19 Serum Studies: Antibody Development Following a SARS-CoV-2 Infection
The Covid-19 Serum Study is a prospective case-control study in
- kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study) or
- patients receiving kidney or liver transplantation after having had a SARS-CoV-2 infection (PRE-TX Covid-19 Serum Study)
Read more
The aim of this study is to evaluate the development of de novo donor specific antibodies (dnDSA) in transplanted patients being hospitalized due to an infection with SARS-CoV-2 (POST-TX Covid-19 Serum Study) as well as in patients receiving kidney or liver transplantation after having had an infection with SARS-CoV-2 prior to transplantation (PRE-TX Covid-19 Serum Study).
Further, the investigators will evaluate possible consequences of having had a SARS-CoV-2 infection prior or after liver or kidney transplantation with regard to graft survival and incidence of graft rejection episodes as well as SARS-CoV-2 specific antibody development after SARS-CoV-2 infection.
- Conditions
- Covid19, Kidney Transplant; Complications, Kidney Transplant Failure and Rejection, Liver Transplant; Complications, Liver Transplant Failure and Rejection
- Keywords
- Covid-19, SARS-CoV-2, Kidney Transplantation, Liver Transplantation, donor-specific antibodies, dnDSA
- Medical subject headings
- COVID-19, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POST-TX Covid-19 Serum Study Case | Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2 | |
| POST-TX Covid-19 Serum Study Control | 2 matched controls without SARS-CoV-2 infection after TX; matching according to * age (18-34, 35-59, 60-75 years) * sex * type of transplantation * time after transplantation (0-180, 181-365, 366-1095, 1096-2555, >2555 days after TX) | |
| PRE-TX Covid-19 Serum Study Case | Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2 | |
| PRE-TX Covid-19 Serum Study Control | 2 matched controls without SARS-CoV-2 infection prior to TX; matching according to * age(18-34, 35-59, 60-75 years) * sex * type of transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dnDSA development (PRE-TX Covid-19 Serum Study)
Measured: Year 1, 2, 3, 5 after day of transplantation
Change in dnDSA development (POST-TX Covid-19 Serum Study)
Measured: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Graft Survival (PRE-TX Covid-19 Serum-Study)
Measured: Year 1, 2, 3, 5 after day of transplantation
Graft Survival (Post-TX Covid-19 Serum-Study)
Measured: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Secondary outcomes (2)
Incidence of graft rejection (PRE-TX Covid-19 Serum Study)
Measured: Year 1, 2, 3, 5 after day of transplantation
Incidence of graft rejection (POST-TX Covid-19 Serum Study)
Measured: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start28 Dec 2020
- Primary completion28 Dec 2021 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Suesal, Heidelberg University
- Investigators
- Caner Suesal, Professor, Principal investigator, Institute of Immunology HeidelbergChristian Morath, Professor, Principal investigator, Department of Nephrology, Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694573
- Sponsor's protocol ID
- CTS Covid-19 Serum Studies
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 19 Jan 2021
- 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 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Transplant Study (CTS) Pre- and Post-Transplantation Covid-19 Serum Studies: Antibody Development Following a SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04694573
- Acronym / sponsor ID
- CTS Covid-19 Serum Studies
- Conditions
- Covid19, Kidney Transplant; Complications, Kidney Transplant Failure and Rejection, Liver Transplant; Complications, Liver Transplant Failure and Rejection
- Keywords
- Covid-19, SARS-CoV-2, Kidney Transplantation, Liver Transplantation, donor-specific antibodies, dnDSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 5 Jan 2021 (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.
The Covid-19 Serum Study is a prospective case-control study in
- kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study) or
- patients receiving kidney or liver transplantation after having had a SARS-CoV-2 infection (PRE-TX Covid-19 Serum Study)
The aim of this study is to evaluate the development of de novo donor specific antibodies (dnDSA) in transplanted patients being hospitalized due to an infection with SARS-CoV-2 (POST-TX Covid-19 Serum Study) as well as in patients receiving kidney or liver transplantation after having had an infection with SARS-CoV-2 prior to transplantation (PRE-TX Covid-19 Serum Study).
Further, the investigators will evaluate possible consequences of having had a SARS-CoV-2 infection prior or after liver or kidney transplantation with regard to graft survival and incidence of graft rejection episodes as well as SARS-CoV-2 specific antibody development after SARS-CoV-2 infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POST-TX Covid-19 Serum Study Case | – | –Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2 |
| POST-TX Covid-19 Serum Study Control | – | –2 matched controls without SARS-CoV-2 infection after TX; matching according to * age (18-34, 35-59, 60-75 years) * sex * type of transplantation * time after transplantation (0-180, 181-365, 366-1095, 1096-2555, >2555 days after TX) |
| PRE-TX Covid-19 Serum Study Case | – | –Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2 |
| PRE-TX Covid-19 Serum Study Control | – | –2 matched controls without SARS-CoV-2 infection prior to TX; matching according to * age(18-34, 35-59, 60-75 years) * sex * type of transplantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney- or liver transplant recipients with a SARS-CoV-2 infection prior to transplantation (PRE-TX Covid-19 Serum Study) or a SARS-CoV-2 infection after transplantation (POST-TX Covid-19 Serum Study), 2 matched controls
Key inclusion criteria (7 listed)
- Kidney-transplant recipients and full-size liver-recipients (de-novo or re-transplanted)
- Participant or legal guardian is willing and able to give informed consent for participation in the trial
- SARS-CoV-2 infection before transplantation (PRE-TX Covid-19 Serum Study) or after transplantation (POST-TX Covid-19 Serum Study)
- Kidney or liver transplantation between Dec 17,2020 - Dec 17, 2021
- Hospitalization due to SARS-CoV-2 infection in between Dec 17,2020 - Dec 17, 2021
Key exclusion criteria (2 listed)
- Participants not meeting the inclusion criteria
- multi-organ transplant recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in dnDSA development (PRE-TX Covid-19 Serum Study)
Time frame: Year 1, 2, 3, 5 after day of transplantation
Change in dnDSA development (POST-TX Covid-19 Serum Study)
Time frame: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Graft Survival (PRE-TX Covid-19 Serum-Study)
Time frame: Year 1, 2, 3, 5 after day of transplantation
Graft Survival (Post-TX Covid-19 Serum-Study)
Time frame: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
2 secondary outcomes
Incidence of graft rejection (PRE-TX Covid-19 Serum Study)
Time frame: Year 1, 2, 3, 5 after day of transplantation
Incidence of graft rejection (POST-TX Covid-19 Serum Study)
Time frame: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Caner Suesal, Professor principal investigator
Institute of Immunology Heidelberg
Christian Morath, Professor principal investigator
Department of Nephrology, Heidelberg
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 Covid19 and Kidney Transplant; Complications, run by Heidelberg University at 1 site in Germany.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caner Suesal, Professor (+49 (0) 6221 56-5545, caner.suesal@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dnDSA development (PRE-TX Covid-19 Serum Study) (time frame: Year 1, 2, 3, 5 after day of transplantation). The study lists 4 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 19 Jan 2021.