Covid19COVATRANSNCT04828460
Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients
An observational study of Covid19 and Kidney Transplantation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Kidney Transplantation
- How many people
- 3,500 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2021to Feb 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplant recipients followed in French transplant centers
Who may be able to join
- Patient, male or female, adult or child (15 years and older)
- Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
- Solid organ transplant recipient
- Transplantation for more than 3 months
Who cannot join
- History of anaphylactic shock or known allergy to PEG
- Known history of COVID or positive Covid serology in the 3 months preceding inclusion
- Formal contraindication to an intra-muscular injection
- Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
- Subject under legal protection
- Subject under guardianship or curatorship
- Patient having expressed his opposition to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Sophie Ohlmann, MD, 0369551320 ext. 33, sophie.ohlmann@chru-strasbourg.fr
About this study
Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.
It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.
Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.
- Conditions
- Covid19, Kidney Transplantation
- Keywords
- covid19, kidney transplantation, seroconversion, immunosuppression, vaccination
- Medical subject headings
- COVID-19, HIV Seropositivity
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 |
|---|---|---|
| Kidney transplant recipients who receive Covid-19 vaccine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Measured: One month after the 2nd injection of the COVID-19 vaccine
Secondary outcomes (5)
Compare the seroconversion between different vaccines
Measured: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Measured: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
Describe the patients characteristics associated with seroconversion
Measured: At Month 24 after the 2nd injection of the COVID-19 vaccine
Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
Measured: At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
Measured: At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start9 Feb 2021
- Primary completionDec 2021 (estimated)
- Study completionFeb 2023 (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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828460
- Sponsor's protocol ID
- 8133
- Acronym
- COVATRANS
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 9 Nov 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 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients
- ClinicalTrials.gov ID
- NCT04828460
- Acronym / sponsor ID
- COVATRANS / 8133
- Conditions
- Covid19, Kidney Transplantation
- Keywords
- covid19, kidney transplantation, seroconversion, immunosuppression, vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 Apr 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.
Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.
It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.
Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients who receive Covid-19 vaccine | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant recipients followed in French transplant centers
Key inclusion criteria (4 listed)
- Patient, male or female, adult or child (15 years and older)
- Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
- Solid organ transplant recipient
- Transplantation for more than 3 months
Key exclusion criteria (7 listed)
- History of anaphylactic shock or known allergy to PEG
- Known history of COVID or positive Covid serology in the 3 months preceding inclusion
- Formal contraindication to an intra-muscular injection
- Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
- Subject under legal protection
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
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Time frame: One month after the 2nd injection of the COVID-19 vaccine
5 secondary outcomes
Compare the seroconversion between different vaccines
Time frame: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Time frame: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
Describe the patients characteristics associated with seroconversion
Time frame: At Month 24 after the 2nd injection of the COVID-19 vaccine
Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
Time frame: At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
Time frame: At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
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 Transplantation, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 7 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 9 Nov 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 France. 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 Sophie Ohlmann, MD (0369551320 ext. 33, sophie.ohlmann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies (time frame: One month after the 2nd injection of the COVID-19 vaccine). 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 9 Nov 2021.