Covid19COVADIALNCT04728828
COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients
An observational study of Covid19, run by Centre Hospitalier de Cornouaille at 1 site in France.
Trial summary
COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Serological COVID-19 vaccine immunogenicity
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 15 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: all in-center haemodialysis patients eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.
Who may be able to join
- all in-center haemodialysis individuals eligible and voluntary to receive one of the approved COVID-19 vaccines.
Who cannot join
- individuals under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France
COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality risk among patients on dialysis (n = 3,285), than the expected 1.2% mortality of propensity-score matched historical controls. Vulnerability in uraemic patients is a combination of intrinsic frailty, increased risk of infection and a high burden of comorbidities. In patients on HD, abnormalities in the immune response may contribute to relative hyporesponsiveness to vaccines. However, patients on HD appear to seroconvert at a similar rate compared to the general population after SARS-CoV-2 infection, suggesting a likelihood of vaccine efficacy but this population has been excluded from vaccine trials. The primary aim of this study is to evaluate antibody synthesis induced after Covid-19 vaccination in a French adult multicentric cohort of in-center haemodialysis patients. The second aim of this study is to identify vaccine non-responders among HD patients and to assess the clinical and biological risk factors associated with non-response.
Read the detailed description
Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis patients?
- Conditions
- Covid19
- Being tested
- Serological COVID-19 vaccine immunogenicity
- Keywords
- Covid19, Vaccine response, Serology, haemodialysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological COVID-19 vaccine immunogenicityBiological
Serological test
| Study group | Role | What they receive |
|---|---|---|
| In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination | Not described Receives: Biological: Serological COVID-19 vaccine immunogenicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody synthesis induced after Covid-19 vaccination (positive or negative)
evaluation of IgG anti-S level
Measured: 1 month after 2nd injection
Secondary outcomes (6)
Lack of immunogenicity
evaluation of IgG anti-S level
Measured: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
COVID-19 incidence
Measured: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Death during follow up
Measured: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
measure antibody response to vaccines in patient subgroup (diabetic patients, patients with auto-immune disease, patients with cancer, patients with an history of solid organ transplantation)
evaluation of IgG anti-S level
Measured: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Longevity of the antibody synthesis induced after Covid-19 vaccination
evaluation of IgG anti-S level
Measured: 3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection
antibody synthesis induced after one injection of Covid-19 vaccine
evaluation of IgG anti-S level
Measured: before second injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start25 Jan 2021
- Primary completion15 Jan 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cornouaille
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional et Universitaire de Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728828
- Sponsor's protocol ID
- COVADIAL
- Acronym
- COVADIAL
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jager KJ, Kramer A, Chesnaye NC, Couchoud C, Sanchez-Alvarez JE, Garneata L, Collart F, Hemmelder MH, Ambuhl P, Kerschbaum J, Legeai C, Del Pino Y Pino MD, Mircescu G, Mazzoleni L, Hoekstra T, Winzeler R, Mayer G, Stel VS, Wanner C, Zoccali C, Massy ZA. Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe. Kidney Int. 2020 Dec;98(6):1540-1548. doi: 10.1016/j.kint.2020.09.006. Epub 2020 Oct 15.
PubMed 32979369ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.
PubMed 33340043Eleftheriadis T, Antoniadi G, Liakopoulos V, Kartsios C, Stefanidis I. Disturbances of acquired immunity in hemodialysis patients. Semin Dial. 2007 Sep-Oct;20(5):440-51. doi: 10.1111/j.1525-139X.2007.00283.x.
PubMed 17897251Mahalingasivam V, Tomlinson L. The seroprevalence of SARS-CoV-2 in patients on haemodialysis. Nat Rev Nephrol. 2021 Apr;17(4):225-226. doi: 10.1038/s41581-020-00379-y.
PubMed 33230249
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France
- ClinicalTrials.gov ID
- NCT04728828
- Acronym / sponsor ID
- COVADIAL / COVADIAL
- Conditions
- Covid19
- Keywords
- Covid19, Vaccine response, Serology, haemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier de CornouailleUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional et Universitaire de Brest
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 28 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.
COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality risk among patients on dialysis (n = 3,285), than the expected 1.2% mortality of propensity-score matched historical controls. Vulnerability in uraemic patients is a combination of intrinsic frailty, increased risk of infection and a high burden of comorbidities. In patients on HD, abnormalities in the immune response may contribute to relative hyporesponsiveness to vaccines. However, patients on HD appear to seroconvert at a similar rate compared to the general population after SARS-CoV-2 infection, suggesting a likelihood of vaccine efficacy but this population has been excluded from vaccine trials. The primary aim of this study is to evaluate antibody synthesis induced after Covid-19 vaccination in a French adult multicentric cohort of in-center haemodialysis patients. The second aim of this study is to identify vaccine non-responders among HD patients and to assess the clinical and biological risk factors associated with non-response.
Detailed description
Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis patients?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination | – | Biological: Serological COVID-19 vaccine immunogenicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all in-center haemodialysis patients eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.
Key inclusion criteria (1 listed)
- all in-center haemodialysis individuals eligible and voluntary to receive one of the approved COVID-19 vaccines.
Key exclusion criteria (1 listed)
- individuals under 18 years of age
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 |
|---|---|---|
| Serological COVID-19 vaccine immunogenicitySerological test | Biological | In-center adult haemodialysis patients eligible and voluntary for COVID19 vaccination |
Primary outcome
antibody synthesis induced after Covid-19 vaccination (positive or negative)
Time frame: 1 month after 2nd injection
evaluation of IgG anti-S level
6 secondary outcomes
Lack of immunogenicity
Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
COVID-19 incidence
Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Death during follow up
Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
measure antibody response to vaccines in patient subgroup (diabetic patients, patients with auto-immune disease, patients with cancer, patients with an history of solid organ transplantation)
Time frame: day 0, before 2nd injection, 1 month after reinjection, 3 months after reinjection, 6 months, 12 months, 24 months
Longevity of the antibody synthesis induced after Covid-19 vaccination
Time frame: 3 months after reinjection, 6 months after reinjection, 12 months after reinjection, 24 months after reinjection
antibody synthesis induced after one injection of Covid-19 vaccine
Time frame: before second injection
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 20 Aug 2024.
- Results publication: PubMed 32979369Jager KJ, Kramer A, Chesnaye NC, Couchoud C, Sanchez-Alvarez JE, Garneata L, Collart F, Hemmelder MH, Ambuhl P, Kerschbaum J, Legeai C, Del Pino Y Pino MD, Mircescu G, Mazzoleni L, Hoekstra T, Winzeler R, Mayer G, Stel VS, Wanner C, Zoccali C, Massy ZA. Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe. Kidney Int. 2020 Dec;98(6):1540-1548. doi: 10.1016/j.kint.2020.09.006. Epub 2020 Oct 15.
- Results publication: PubMed 33340043ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.
- Results publication: PubMed 17897251Eleftheriadis T, Antoniadi G, Liakopoulos V, Kartsios C, Stefanidis I. Disturbances of acquired immunity in hemodialysis patients. Semin Dial. 2007 Sep-Oct;20(5):440-51. doi: 10.1111/j.1525-139X.2007.00283.x.
- Results publication: PubMed 33230249Mahalingasivam V, Tomlinson L. The seroprevalence of SARS-CoV-2 in patients on haemodialysis. Nat Rev Nephrol. 2021 Apr;17(4):225-226. doi: 10.1038/s41581-020-00379-y.
- 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 Covid19, run by Centre Hospitalier de Cornouaille 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 1 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 20 Aug 2024. 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?
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?
antibody synthesis induced after Covid-19 vaccination (positive or negative) (time frame: 1 month after 2nd injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728828, which also lists 4 linked publications.
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 20 Aug 2024.