Solid Organ Transplant RecipientsTIXCI-TRANSNCT05234398
TIXAGEVIMAB/CILGAVIMAB Protection of Covid-19 in Transplanted Patients
An observational study of Solid Organ Transplant Recipients, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Covid-19 has a very bad prognosis in solid organ transplant recipients with a 60 days-mortality exceeding 20%. For this reason, transplant patients were prioritized to receive Covid-19 vaccination since December 2020 in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplant Recipients
- What is being tested?
- Blood and saliva samplings
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2022to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 160 solid organ transplant patients will be enrolled in the study. Recruitment will be performed among transplant patients at the two transplant centers participating in the study during a follow-up visit, after receipt of their serology results. Patients will be allocated into two groups: * Group 1 (100 patients): naïve patients, who have never received anti-SARS CoV2 monoclonal antibodies. * Group 2 (60 patients): patients who have previously received anti-SARS Cov2 monoclonal antibodies.
Who may be able to join
- Male or female, 18 years of age or older
- Recipient of a solid organ transplant
- Subject affiliated with a health insurance company
- Patient able to understand the objectives and risks of the research and to give a non-objection
- Patient with a post-vaccination anti-Spike IgG (or RBD - Receptor Blinding Domain) titer of less than 30 BAU/ml ( (binding antibody units) measured at least 14 days after completion of an intensified vaccination regimen (at least 3 doses of mRNA vaccine) and prior to administration of anti-SARS-Cov-2 monoclonal antibodies.
- Group 1 criteria: Naïve patients, never having received anti-SARS CoV2 monoclonal antibodies.
- Group 2 criteria: Patients who have previously received anti-SARS Cov2 monoclonal antibodies
Who cannot join
- History of anaphylactic shock or known allergy to TIXAGEVIMAB/CILGAVIMAB
- Known history of Covid-19 or positive Covid-19 serology within 3 months prior to inclusion
- History of myocardial infarction or coronary artery disease within 3 months prior to inclusion
- Contraindication to an intramuscular injection
- Impossibility to give to the subject an informed information
- Subject under legal protection, guardianship or curatorship
Show all 10Show fewer
- Plasmapheresis in progress or planned
- Weight less than 48 kg
- Patient participating in another interventional research study in progress
- Pregnant, parturient, or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Néphrologie, Transplantation et Immunologie Clinique Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69437
Service de Néphrologie et Transplantation, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: TIXAGEVIMAB/CILGAVIMAB for Covid-19 Pre-exposition Prophylaxis in Solid Organ Transplanted Recipients
Covid-19 has a very bad prognosis in solid organ transplant recipients with a 60 days-mortality exceeding 20%. For this reason, transplant patients were prioritized to receive Covid-19 vaccination since December 2020 in France. Unfortunately, the vaccine response of these patients is insufficient after a standard vaccine regimen including 2 doses of mRNA (messenger ribonucleic acid) vaccine with a 50% seroconversion rate in many cohorts. As a result, on the advice of the "Conseil National d'Orientation Vaccinale", the French Health Authorities has authorized physicians to offer a 3rd dose of vaccine to organ transplant patients since April 11, 2021. The subsequent studies showed that half of the patients who did not seroconvert after the 2nd dose did develop a vaccine response after the third dose. For patients who do not respond after the 3rd dose, the clinicians are now allowed to offer a 4th dose of vaccine.
Unfortunately, approximately 25% of patients still remain non-responders to this 3- or 4-doses vaccine regimen. In addition, transplant recipients who do not developed a vaccine response after the 3rd dose are very unlikely to respond after the 4th dose. For patients who do not respond to the vaccination, the French Health Authorities had authorized the infusion of SARS Cov2 (Severe Acute Respiratory Syndrome Coronavirus 2) monoclonal antibodies as a pre-exposition prophylaxis in immunocompromised patients.
Read more
The value of using the TIXAGEVIMAB/CILGAVIMAB monoclonal antibody cocktail as primary prophylaxis has been demonstrated in the general population but this study did not include immunocompromised patients.
Here, the investigators propose to study the pharmacokinetics of TIXAGEVIMAB/CILGAVIMAB given in a pre-exposition prophylaxis scheme in non-responder solid organ transplanted patients after an adapted vaccinal scheme (i.e. 3 doses or more of mRNA vaccines).
- Conditions
- Solid Organ Transplant Recipients
- Being tested
- Blood and saliva samplings
- Keywords
- monoclonal antibody, protective level of SARS CoV2 antibodies, pharmacokinetic of anti-SARS CoV2 antibodies, SARS CoV2 infection, viral neutralization capacity, anti-Nucleocapsid IgG (Immunoglobulin G)
- 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 and saliva samplingsBiological
At each protocol visits, on the occasion of a care collection, additional blood and saliva samples will be taken specifically for the study, with a total volume of blood of 38 mL, and a saliva sample of 1.5 to 2 mL per visit (inclusion, month 1, month 4, month 6, month 9 and month 12), corresponding to routine care.
| Study group | Role | What they receive |
|---|---|---|
| Naïve patients | This study involve non-responder solid organ transplanted patients after an adapted vaccinal scheme (i.e. 3 doses or more of mRNA vaccines).
Patients included in Group 1 are naïve patients; there have never received anti-SARS Cov2 monoclonal antibodies.
They will have additional blood and saliva samplings during their study visits, which are included in their usual medical follow-up. Receives: Biological: Blood and saliva samplings | |
| Switched patients | This study involve non-responder solid organ transplanted patients after an adapted vaccinal scheme (i.e. 3 doses or more of mRNA vaccines).
Patients included in Group 2 have previously received anti-SARS Cov2 monoclonal antibodies.
They will have additional blood and saliva samplings during their study visits, which are included in their usual medical follow-up. Receives: Biological: Blood and saliva samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose serum has viral neutralization capacity in vitro at M6 after TIXAGEVIMAB/CILGAVIMAB injection.
Viral neutralization capacity will be analyzed by performing in-vitro neutralization tests from blood samples of enrolled patients.
Samples will be analyzed centrally by virology Laboratory of Strasbourg Hospital throughout the study.
Measured: At Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: This project will be integrated into an ongoing project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier THAUNAT, MD-PhD, Principal investigator, Service de Néphrologie, Transplantation et Immunologie Clinique Hôpital Edouard Herriot - Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234398
- Sponsor's protocol ID
- 69HCL21_1433
- Other IDs
- 2021-A03245-36
- Acronym
- TIXCI-TRANS
- Status last verified
- Aug 2022
- First submitted
- 8 Feb 2022
- Last updated
- 1 Sep 2022
- 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 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIXAGEVIMAB/CILGAVIMAB for Covid-19 Pre-exposition Prophylaxis in Solid Organ Transplanted Recipients
- ClinicalTrials.gov ID
- NCT05234398
- Acronym / sponsor ID
- TIXCI-TRANS / 69HCL21_1433
- Conditions
- Solid Organ Transplant Recipients
- Keywords
- monoclonal antibody, protective level of SARS CoV2 antibodies, pharmacokinetic of anti-SARS CoV2 antibodies, SARS CoV2 infection, viral neutralization capacity, anti-Nucleocapsid IgG (Immunoglobulin G)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This project will be integrated into an ongoing project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 10 Feb 2022 (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.
Covid-19 has a very bad prognosis in solid organ transplant recipients with a 60 days-mortality exceeding 20%. For this reason, transplant patients were prioritized to receive Covid-19 vaccination since December 2020 in France. Unfortunately, the vaccine response of these patients is insufficient after a standard vaccine regimen including 2 doses of mRNA (messenger ribonucleic acid) vaccine with a 50% seroconversion rate in many cohorts. As a result, on the advice of the "Conseil National d'Orientation Vaccinale", the French Health Authorities has authorized physicians to offer a 3rd dose of vaccine to organ transplant patients since April 11, 2021. The subsequent studies showed that half of the patients who did not seroconvert after the 2nd dose did develop a vaccine response after the third dose. For patients who do not respond after the 3rd dose, the clinicians are now allowed to offer a 4th dose of vaccine.
Unfortunately, approximately 25% of patients still remain non-responders to this 3- or 4-doses vaccine regimen. In addition, transplant recipients who do not developed a vaccine response after the 3rd dose are very unlikely to respond after the 4th dose. For patients who do not respond to the vaccination, the French Health Authorities had authorized the infusion of SARS Cov2 (Severe Acute Respiratory Syndrome Coronavirus 2) monoclonal antibodies as a pre-exposition prophylaxis in immunocompromised patients.
The value of using the TIXAGEVIMAB/CILGAVIMAB monoclonal antibody cocktail as primary prophylaxis has been demonstrated in the general population but this study did not include immunocompromised patients.
Here, the investigators propose to study the pharmacokinetics of TIXAGEVIMAB/CILGAVIMAB given in a pre-exposition prophylaxis scheme in non-responder solid organ transplanted patients after an adapted vaccinal scheme (i.e. 3 doses or more of mRNA vaccines).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naïve patients | – | Biological: Blood and saliva samplingsThis study involve non-responder solid organ transplanted patients after an adapted vaccinal scheme (i.e. 3 doses or more of mRNA vaccines). Patients included in Group 1 are naïve patients; there have never received anti-SARS Cov2 monoclonal antibodies. They will have additional blood and saliva samplings during their study visits, which are included in their usual medical follow-up. |
| Switched patients | – | Biological: Blood and saliva samplingsThis study involve non-responder solid organ transplanted patients after an adapted vaccinal scheme (i.e. 3 doses or more of mRNA vaccines). Patients included in Group 2 have previously received anti-SARS Cov2 monoclonal antibodies. They will have additional blood and saliva samplings during their study visits, which are included in their usual medical follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 160 solid organ transplant patients will be enrolled in the study. Recruitment will be performed among transplant patients at the two transplant centers participating in the study during a follow-up visit, after receipt of their serology results. Patients will be allocated into two groups: * Group 1 (100 patients): naïve patients, who have never received anti-SARS CoV2 monoclonal antibodies. * Group 2 (60 patients): patients who have previously received anti-SARS Cov2 monoclonal antibodies.
Key inclusion criteria (7 listed)
- Male or female, 18 years of age or older
- Recipient of a solid organ transplant
- Subject affiliated with a health insurance company
- Patient able to understand the objectives and risks of the research and to give a non-objection
- Patient with a post-vaccination anti-Spike IgG (or RBD - Receptor Blinding Domain) titer of less than 30 BAU/ml ( (binding antibody units) measured at least 14 days after completion of an intensified vaccination regimen (at least 3 doses of mRNA vaccine) and prior to administration of anti-SARS-Cov-2 monoclonal antibodies.
Key exclusion criteria (10 listed)
- History of anaphylactic shock or known allergy to TIXAGEVIMAB/CILGAVIMAB
- Known history of Covid-19 or positive Covid-19 serology within 3 months prior to inclusion
- History of myocardial infarction or coronary artery disease within 3 months prior to inclusion
- Contraindication to an intramuscular injection
- Impossibility to give to the subject an informed information
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 and saliva samplingsAt each protocol visits, on the occasion of a care collection, additional blood and saliva samples will be taken specifically for the study, with a total volume of blood of 38 mL, and a saliva sample of 1.5 to 2 mL per visit (inclusion, month 1, month 4, month 6, month 9 and month 12), corresponding to routine care. | Biological | Naïve patients, Switched patients |
Primary outcome
Percentage of patients whose serum has viral neutralization capacity in vitro at M6 after TIXAGEVIMAB/CILGAVIMAB injection.
Time frame: At Month 6.
Viral neutralization capacity will be analyzed by performing in-vitro neutralization tests from blood samples of enrolled patients. Samples will be analyzed centrally by virology Laboratory of Strasbourg Hospital throughout the study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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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.
Olivier THAUNAT, MD-PhD principal investigator
Service de Néphrologie, Transplantation et Immunologie Clinique Hôpital Edouard Herriot - Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplant Recipients, run by Hospices Civils de Lyon at 2 sites 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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients whose serum has viral neutralization capacity in vitro at M6 after TIXAGEVIMAB/CILGAVIMAB injection. (time frame: At Month 6.). 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 1 Sep 2022.