COVIDCOVCKDNCT04367714
Antibody Response Against SARS-CoV-2 in Dialysis Patients During COVID-19
An observational study of COVID and Terminal Renal Insufficiency, run by Region MidtJylland Denmark at 1 site in Denmark.
Trial summary
Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID, Terminal Renal Insufficiency
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2020to 1 Dec 2021
- How long will I take part?
- 9 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dilaysis patients on 3 Danish center in Jutland
Who may be able to join
- Dialysis
Who cannot join
- Not willing to give consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Godstrup Hospital
Herning, 7400
Frank Mose, 28531257, frchri@rm.dk
About this study
Official title: Antistof Respons Mod SARS-CoV-2 Hos Dialysepatienter i Forbindelse Med COVID-19
Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020
Read the detailed description
Blood samples are collected every 14 days
- Conditions
- COVID, Terminal Renal Insufficiency
- Keywords
- COVID-19, CKD 5
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
AAntibody response
IgM and IgG against SARS-CoV-2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start15 Mar 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- 300 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Central Jutland Regional Hospital, Aalborg University Hospital
- Responsible party
- Principal investigator, Frank Mose, Region MidtJylland Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367714
- Sponsor's protocol ID
- FHM-1-2020
- Acronym
- COVCKD
- Status last verified
- Dec 2020
- First submitted
- 27 Apr 2020
- Last updated
- 30 Dec 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antistof Respons Mod SARS-CoV-2 Hos Dialysepatienter i Forbindelse Med COVID-19
- ClinicalTrials.gov ID
- NCT04367714
- Acronym / sponsor ID
- COVCKD / FHM-1-2020
- Conditions
- COVID, Terminal Renal Insufficiency
- Keywords
- COVID-19, CKD 5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Central Jutland Regional Hospital, Aalborg University Hospital
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 29 Apr 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.
Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020
Detailed description
Blood samples are collected every 14 days
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dilaysis patients on 3 Danish center in Jutland
Key inclusion criteria (1 listed)
- Dialysis
Key exclusion criteria (1 listed)
- Not willing to give 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
AAntibody response
Time frame: 1 year
IgM and IgG against SARS-CoV-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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.
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 COVID and Terminal Renal Insufficiency, run by Region MidtJylland Denmark at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 30 Dec 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 Denmark. 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 Frank Mose, MD (+4528531257, frchri@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAntibody response (time frame: 1 year). 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 30 Dec 2020.