DialysisCOV-HDNCT04633915
Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
An observational study of Dialysis and Covid19, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers. The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 51 participants
- Where
- 1 siteRussia
- Study dates
- 26 Nov 2020to 18 Jul 2021
- 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
- Adult, Older adult
Study population: Patient ≥ 18 years old who were diagnosed with SARS-CoV-2 infection confirmed by PCR or strongly suspected on computed tomography within 10 weeks prior enrollment. Main group include patients with chronic kidney disease stage 5, receiving hemodialysis as a renal replacement therapy. The another group include volunteers who are not dialysis-dependent.
Who may be able to join
- Age 18 years or older
- SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography
- Providing informed consent
Who cannot join
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint-Petersburg State University Hospital
Saint Petersburg, 190103
About this study
Official title: A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers.
The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups.
To determine whether there is a statistically significant interaction between factors "group" and "time" on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.
Read the detailed description
In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.
- Keywords
- antibodies, IgG, CKD, hemodialysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis | Patients with CKD stage 5, treated with maintenance hemodialysis | |
| Healthy | Volunteers who are not dialysis-dependent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-SARS-COV-2 IgG level
Measured: 16 weeks
Secondary outcomes (2)
Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups
Measured: Day 1, weeks 8, 16
Anti-SARS-COV-2 IgG level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start26 Nov 2020
- Primary completion18 Jul 2021
- Study completion18 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Parshina, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633915
- Sponsor's protocol ID
- COVID
- Acronym
- COV-HD
- Status last verified
- Aug 2021
- First submitted
- 15 Nov 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
- ClinicalTrials.gov ID
- NCT04633915
- Acronym / sponsor ID
- COV-HD / COVID
- Keywords
- antibodies, IgG, CKD, hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 18 Jul 2021 (actual)
- First posted
- 18 Nov 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.
This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers.
The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups.
To determine whether there is a statistically significant interaction between factors "group" and "time" on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.
Detailed description
In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysis | – | –Patients with CKD stage 5, treated with maintenance hemodialysis |
| Healthy | – | –Volunteers who are not dialysis-dependent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient ≥ 18 years old who were diagnosed with SARS-CoV-2 infection confirmed by PCR or strongly suspected on computed tomography within 10 weeks prior enrollment. Main group include patients with chronic kidney disease stage 5, receiving hemodialysis as a renal replacement therapy. The another group include volunteers who are not dialysis-dependent.
Key inclusion criteria (3 listed)
- Age 18 years or older
- SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography
- Providing informed consent
Key exclusion criteria (1 listed)
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti-SARS-COV-2 IgG level
Time frame: 16 weeks
2 secondary outcomes
Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups
Time frame: Day 1, weeks 8, 16
Anti-SARS-COV-2 IgG level
Time frame: 8 weeks
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 3 Aug 2021.
- 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 Dialysis and Covid19, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 3 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 3 Aug 2021. 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 Russia. 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?
Anti-SARS-COV-2 IgG level (time frame: 16 weeks). 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 3 Aug 2021.