SARS-CoV-2 InfectionRePAiRNCT04495764
Registry of Sustained Immunity to COVID-19 Among ESKD Patients
An observational study of SARS-CoV-2 Infection and Anti-SARS-CoV-2 Infection, run by Davita Clinical Research at 12 sites in United States.
Trial summary
This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center. The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2 Infection, Anti-SARS-CoV-2 Infection
- How many people
- 2,315 participants
- Where
- 12 sitesUnited States
- Study dates
- 20 Jul 2020to 12 Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Between ≥18 and 80 years of age, inclusive. 2. Ability to provide informed consent. 3. Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
Who may be able to join
- Between ≥18 and 80 years of age, inclusive.
- Ability to provide informed consent.
- Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
DCR Connecticut
Bridgeport, Connecticut, 06606
DCR Canton
Canton, Ohio, 44718
DCR El Paso
El Paso, Texas, 79925
DCR Las Vegas
Las Vegas, Nevada, 89128
DCR Lewisville
Lewisville, Texas, 75057
DCR Milwaukee
Milwaukee, Wisconsin, 53226
DCR Twin Cities
Minneapolis, Minnesota, 55404
DCR Norfolk
Norfolk, Virginia, 23502
DCR San Antonio
San Antonio, Texas, 78215
DCR San Antonio
San Antonio, Texas, 78230
DCR Bronx
The Bronx, New York, 10461
DCR Victorville
Victorville, California, 92394
About this study
This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.
The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.
Read the detailed description
This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.
The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.
Following informed consent, participants will undergo baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19. Enrollment will continue until the total sample size of 2500 is reached or until the study sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The relationship between baseline serologic status and subsequent infection/disease will be determined.
This study will have 2 distinct phases.
Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at different times at the active sites. Participants will be consented and enrolled and blood will be collected for anti-SARS-CoV-2 antibodies.
Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study location may be triggered to start at separate times. Study participants will be followed prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor trigger and will occur once monthly for 4 months.
- Conditions
- SARS-CoV-2 Infection, Anti-SARS-CoV-2 Infection
- Keywords
- Immunoglobulin G, Immunoglobulin M
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-SARS-CoV-2 antibodies
Measured: Through study completion (5 visits), an average of 6 months
Incidence and severity of COVID-19
Measured: Through study completion (5 visits), an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start20 Jul 2020
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- 2,315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Davita Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesca Tentori, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495764
- Sponsor's protocol ID
- 20-M-0044-00
- Acronym
- RePAiR
- Status last verified
- May 2021
- First submitted
- 22 Jul 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Sustained Immunity to COVID-19 Among ESKD Patients
- ClinicalTrials.gov ID
- NCT04495764
- Acronym / sponsor ID
- RePAiR / 20-M-0044-00
- Conditions
- SARS-CoV-2 Infection, Anti-SARS-CoV-2 Infection
- Keywords
- Immunoglobulin G, Immunoglobulin M
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,315 participants (actual)
- Lead sponsor
- Davita Clinical ResearchIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 3 Aug 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 a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.
The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.
Detailed description
This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.
The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.
Following informed consent, participants will undergo baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19. Enrollment will continue until the total sample size of 2500 is reached or until the study sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The relationship between baseline serologic status and subsequent infection/disease will be determined.
This study will have 2 distinct phases.
Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at different times at the active sites. Participants will be consented and enrolled and blood will be collected for anti-SARS-CoV-2 antibodies.
Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study location may be triggered to start at separate times. Study participants will be followed prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor trigger and will occur once monthly for 4 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Between ≥18 and 80 years of age, inclusive. 2. Ability to provide informed consent. 3. Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
Key inclusion criteria (3 listed)
- Between ≥18 and 80 years of age, inclusive.
- Ability to provide informed consent.
- Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
Key exclusion criteria (1 listed)
- -
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 antibodies
Time frame: Through study completion (5 visits), an average of 6 months
Incidence and severity of COVID-19
Time frame: Through study completion (5 visits), an average of 6 months
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 27 May 2021.
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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.
Francesca Tentori, MD principal investigator
Davita Clinical Research
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and Anti-SARS-CoV-2 Infection, run by Davita Clinical Research at 12 sites in United States.
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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 antibodies (time frame: Through study completion (5 visits), an average of 6 months). The study lists 2 primary outcomes in all. 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 27 May 2021.