Chronic Hemodialysis Patients Clinical Trial
— SeroCOVIDialOfficial title:
SeroCOVIDial Study: Assessment of SARS-COV2 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, a Cohort Study
Background: The preventive containment measures implemented in the COVID-19 pandemic are not
feasible in chronic hemodialysis patients (HD) who need to attend their dialysis sessions 3
times a week. HD patients display frequent comorbidities (such as diabetes and cardiovascular
disease), and immune deficiency, which expose them to an increased risk of severe forms of
COVID-19. They can be infected in their dialysis center despite the measures taken to limit
this risk. Their caregivers are also at risk of infection if patients carry the virus.
Dialysis centers face major organizational challenges in terms of patient and caregiver
safety. Knowing the viral serological status of HD patients and caregivers, the proportion of
asymptomatic forms, and the persistence and effectiveness of immunization over time would be
of major interest for patient management and the organization of dialysis care.
Research objectives: The primary objective of SeroCOVIDial is to assess the prevalence of
SARS-COV2 seroconversion at inclusion (M0) in a cohort of HD patients, using the rapid
serological test. Secondary Objectives : 1) assess the prevalence of SARS-COV2 seroconversion
in dialysis caregivers at M0, using the same test; 2) assess the proportion of asymptomatic
forms of COVID-19 in HD patients and in their caregivers; 3) compare the prevalence of
seroconversion and the proportion of asymptomatic forms in HD patients according to their
clinical characteristics and co-morbidities; 4) assess the prevalence of SARS-COV2
seroconversion in participants who had a documented COVID-19; 5) evaluate the spread of the
epidemic and the kinetics of seroconversion in patients and caregivers by a second test
performed at M3; 6) evaluate the predictive value of SARS-COV2 seroconversion at M0 on the
risk of developing a symptomatic COVID-19 infection within 6 months, in patients and
caregivers; 7) evaluate a posteriori the intrinsic diagnostic performances of the test in
comparison with serological gold standards (ELISA and seroneutralization).
Methods: Multicenter cohort study, carried out in 4 dialysis facilities in Aix-Marseille.
Procedure: collection of clinical data and rapid serological tests carried out at M0 and M3,
in patients and caregivers (a systematic screening for COVID-19 symptoms has been carried out
in all HD patients in the 4 participating centers since the beginning of the pandemic in
France).
Number of participants: 800 eligible persons (561 HD patients, and 239 caregivers). Material
tested: rapid Biosynex serological test on 1 drop of blood, and 1 tube of frozen serum for
patients at M0 and M3. Clinical data will also be collected.
Primary endpoint: prevalence of SARS-COV2 seroconversion in HD patients. Maximum duration of
participation for each patient: 6 months. Duration of research: 6 months and 2 weeks
(inclusions over 2 weeks).
| Status | Recruiting |
| Enrollment | 800 |
| Est. completion date | December 15, 2020 |
| Est. primary completion date | December 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject of 18 years of age or older - Chronic hemodialysis patients or caregiver of chronic hemodialysis patients - signed consent - Social Security affiliation. Exclusion Criteria: - Pregnant or breastfeeding women - Minors - Adults under guardianship and trusteeship, persons deprived of their liberty, - Participation in a SARS-COV2 vaccine study |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille | Paca |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The prevalence of SARS-COV2 seroconversion in chronic hemodialysis patients | Proportion of positive patients out of the total number of patients tested | 6 months | |
| Secondary | The prevalence of SARS-COV2 seroconversion in dialysis caregivers | Proportion of positive caregivers out of the total number of caregivers tested | 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00840372 -
Semi-blunt Needles: is Outcome Better?
|
N/A | |
| Not yet recruiting |
NCT05410275 -
Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients
|
Phase 3 |