COVADIAL - Immunogenicity of COVID-19 Vaccine in Hemodialysis Patients
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- STATUS
- Recruiting
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- End date
- Aug 15, 2023
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- participants needed
- 500
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- sponsor
- Centre Hospitalier de Cornouaille
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 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.
Description
Hemodialysis patients were excluded from COVID19 vaccine response studies: seroprotection rate? Long-term protection? Different regimens to offer to hemodialysis patients?
Details
| Condition | COVID19 |
|---|---|
| Treatment | Serological COVID-19 vaccine immunogenicity |
| Clinical Study Identifier | NCT04728828 |
| Sponsor | Centre Hospitalier de Cornouaille |
| Last Modified on | 4 March 2021 |
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