Chronic Hemodialysis PatientsSeroCOVIDialNCT04420338
SeroCOVIDial Study: Assessment of COVID-19 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, a Cohort Study
A study testing Blood sample and Serum tube collection in people with Chronic Hemodialysis Patients and Caregivers of Chronic Hemodialysis Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hemodialysis Patients, Caregivers of Chronic Hemodialysis Patients
- What is being tested?
- Blood sample and Serum tube collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2020to 15 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Subject of 18 years of age or older
- Chronic hemodialysis patients or caregiver of chronic hemodialysis patients
- signed consent
- Social Security affiliation.
Who cannot join
- Pregnant or breastfeeding women
- Minors
- Adults under guardianship and trusteeship, persons deprived of their liberty,
- Participation in a SARS-COV2 vaccine study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, PACA, 13354
Noémie JOURDE-CHICHE, PU-PH, 491383042 ext. +33, Noemie.JOURDE@ap-hm.fr
Philippe BRUNET, PU-PH
About this study
Official 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).
Read more
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).
- Being tested
- Blood sample, Serum tube collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
rapid serological tests carried out
Serum tube collectionBiological
SARS-COV2 seroconversion assay
| Study group | Role | What they receive |
|---|---|---|
| Chronic hemodialysis patients | Experimental | Not described Receives: Biological: Blood sample; Biological: Serum tube collection |
| Caregivers of chronic hemodialysis patients | Experimental | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of SARS-COV2 seroconversion in chronic hemodialysis patients
Proportion of positive patients out of the total number of patients tested
Measured: 6 months
Secondary outcomes (1)
The prevalence of SARS-COV2 seroconversion in dialysis caregivers
Proportion of positive caregivers out of the total number of caregivers tested
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start5 Jun 2020
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARBAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420338
- Sponsor's protocol ID
- 2020-34
- Other IDs
- 2020-A01515-34
- Acronym
- SeroCOVIDial
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeroCOVIDial Study: Assessment of SARS-COV2 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, a Cohort Study
- ClinicalTrials.gov ID
- NCT04420338
- Acronym / sponsor ID
- SeroCOVIDial / 2020-34
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic hemodialysis patients | Experimental | Biological: Blood sample, Biological: Serum tube collection |
| Caregivers of chronic hemodialysis patients | Experimental | Biological: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject of 18 years of age or older
- Chronic hemodialysis patients or caregiver of chronic hemodialysis patients
- signed consent
- Social Security affiliation.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Minors
- Adults under guardianship and trusteeship, persons deprived of their liberty,
- Participation in a SARS-COV2 vaccine study
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 samplerapid serological tests carried out | Biological | Caregivers of chronic hemodialysis patients, Chronic hemodialysis patients |
| Serum tube collectionSARS-COV2 seroconversion assay | Biological | Chronic hemodialysis patients |
Primary outcome
The prevalence of SARS-COV2 seroconversion in chronic hemodialysis patients
Time frame: 6 months
Proportion of positive patients out of the total number of patients tested
1 secondary outcome
The prevalence of SARS-COV2 seroconversion in dialysis caregivers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Jean-Olivier ARBAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Serum tube collection in people with Chronic Hemodialysis Patients and Caregivers of Chronic Hemodialysis Patients, run by Assistance Publique Hopitaux De Marseille 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 4 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 17 Jun 2020. 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 Philippe BRUNET, PU-PH (491383042 ext. +33, philippe.brunet@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of SARS-COV2 seroconversion in chronic hemodialysis patients (time frame: 6 months). 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 17 Jun 2020.