SARS-CoV-2 Infection (Asymptomatic)COPENCT04495907
COVID-19 Progression in End-Stage Kidney Disease
An observational study of SARS-CoV-2 Infection (Asymptomatic) and SARS-CoV-2 Infection (Symptomatic), run by Davita Clinical Research at 11 sites in United States.
Trial summary
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2 Infection (Asymptomatic), SARS-CoV-2 Infection (Symptomatic)
- How many people
- 412 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Aug 2020to 31 Aug 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: Type A \& B participants must meet all of the following criteria: 1. Is between 18 and 80 years of age, inclusive. 2. Ability to provide informed consent. 3. Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center. 3.2 Additional Inclusion Criteria: Type B (prior participant in genomics study) Type B participants must meet all of the above criteria and the following criteria: 1. Enrollment in prior genomics study.
Who may be able to join
- Is 18 years or older at the time of consent
- Ability to provide informed consent.
- Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
- Enrollment in prior genomics study (Additional criteria for type B only)
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 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, 78230
DCR Bronx
The Bronx, New York, 10461
DCR Victorville
Victorville, California, 92394
About this study
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
Read the detailed description
COVID-19 is a novel illness caused by the SARS-CoV-2 virus. It was declared as a global pandemic on March 11, 2020 and since that time there have been outbreaks on every continent except for Antarctica. Preliminary understanding of the virus suggests that some fraction of the population does not manifest clinical disease in response to infection, others manifest a relatively benign course of illness, and still others develop a fulminant course that eventuates in the need for intensive care, mechanical ventilation, or even death. The genetic and epigenetic basis for differential susceptibility remains unknown.
Patients receiving hemodialysis provide a good opportunity to understand genetic and epigenetic susceptibility to SARS-CoV-2. By virtue of their ongoing requirements for care, such patients cannot shelter at home or maintain social distancing, but must instead report to a clinical care setting on a thrice weekly basis. Moreover, such patients often travel to and from dialysis using shared ride services, which furthers opportunity for exposure. Preliminary estimates suggest that rates of SARS-CoV-2 positivity are 2 to 5-fold higher among hemodialysis patients than in the general public. Furthermore, frequent contact with the health care system among dialysis patients makes tracking clinical course comparatively easy.
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
- 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 |
|---|---|---|
| Group I | Group I- Asymptomatic patients with SARS-CoV-2 Infection | |
| Group II | Group II-Symptomatic patients with SARS-CoV-2 Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 IgG
Measured: An average of 6 months
Anti-SARS-CoV-2 IgG
Measured: 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 start6 Aug 2020
- Primary completion9 Apr 2021
- Study completion31 Aug 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 Infection (Asymptomatic)Studies 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
- Other
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Davita Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Connaire, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495907
- Sponsor's protocol ID
- 20-M-0047-00
- Acronym
- COPE
- Status last verified
- Mar 2022
- First submitted
- 30 Jul 2020
- Last updated
- 22 Mar 2022
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Progression in End-Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT04495907
- Acronym / sponsor ID
- COPE / 20-M-0047-00
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Davita Clinical ResearchIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 31 Aug 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.
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
Detailed description
COVID-19 is a novel illness caused by the SARS-CoV-2 virus. It was declared as a global pandemic on March 11, 2020 and since that time there have been outbreaks on every continent except for Antarctica. Preliminary understanding of the virus suggests that some fraction of the population does not manifest clinical disease in response to infection, others manifest a relatively benign course of illness, and still others develop a fulminant course that eventuates in the need for intensive care, mechanical ventilation, or even death. The genetic and epigenetic basis for differential susceptibility remains unknown.
Patients receiving hemodialysis provide a good opportunity to understand genetic and epigenetic susceptibility to SARS-CoV-2. By virtue of their ongoing requirements for care, such patients cannot shelter at home or maintain social distancing, but must instead report to a clinical care setting on a thrice weekly basis. Moreover, such patients often travel to and from dialysis using shared ride services, which furthers opportunity for exposure. Preliminary estimates suggest that rates of SARS-CoV-2 positivity are 2 to 5-fold higher among hemodialysis patients than in the general public. Furthermore, frequent contact with the health care system among dialysis patients makes tracking clinical course comparatively easy.
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –Group I- Asymptomatic patients with SARS-CoV-2 Infection |
| Group II | – | –Group II-Symptomatic patients with SARS-CoV-2 Infection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type A \& B participants must meet all of the following criteria: 1. Is between 18 and 80 years of age, inclusive. 2. Ability to provide informed consent. 3. Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center. 3.2 Additional Inclusion Criteria: Type B (prior participant in genomics study) Type B participants must meet all of the above criteria and the following criteria: 1. Enrollment in prior genomics study.
Key inclusion criteria (4 listed)
- Is 18 years or older at the time of consent
- Ability to provide informed consent.
- Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
- Enrollment in prior genomics study (Additional criteria for type B only)
Key exclusion criteria (0 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
SARS-CoV-2 IgG
Time frame: An average of 6 months
Anti-SARS-CoV-2 IgG
Time frame: 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 22 Mar 2022.
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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.
Jeffrey Connaire, MD principal investigator
Davita Clinical Research
11 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 (Asymptomatic) and SARS-CoV-2 Infection (Symptomatic), run by Davita Clinical Research at 11 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 4 inclusion and 0 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
SARS-CoV-2 IgG (time frame: 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 22 Mar 2022.