COVID-19 in Patients with ESRD
What is the purpose of this study?The purpose of this study is to examine levels of SARS-CoV-2 antibodies in ESRD patients undergoing hemodialysis who receive the SARS-CoV-2 vaccine. This knowledge will lead to a better understanding of antibody durability in ESRD patients undergoing hemodialysis who receive the vaccine.
The study does not provide the vaccine, and study team members will not be offering guidance as to whether or not one should receive a SARS-CoV-2 vaccine. If participants will be receiving a vaccine and are interested in the study, we will collect a blood sample before vaccination, and collect samples at sequential time points post-immunization.
Why should I refer my patients to participate in the COPE Study?Because ESRD patients undergoing hemodialysis have traditionally been excluded from vaccine trials, little is known about durable immunity in this patient population following vaccination.
What does the study involve?This study will involve the completion of a short survey and at-home, do-it-yourself at-home blood collection using the Seventh Sense TAP™ II device. See the instructional video below about the ease of use of the collection device. Blood will be collected at baseline and several time points after vaccination. This is then mailed back and run in Johns Hopkins labs for SARS-CoV-2 antibody testing. There is no cost to participants. No in-person study visits are required, and in fact, the entire study can be completed from home.
What data is being collected?The survey includes questions on demographics, general health, comorbidities, and prior COVID-19 diagnoses. Blood samples will be analyzed for IgA and IgG antibody titers using EUROIMMUN ELISA at Johns Hopkins.
Some of my patients have received convalescent plasma, Regeneron, or some other “antibody-based” therapy for COVID-19. Are they eligible to participate?Yes.
Some of my patients have already received the COVID-19 vaccine. Are they eligible to participate?Yes.
How do I inform my patients about the study?Please ask your patients to visit this website. Once on the site, they can fill out a short online form, which will determine whether they are eligible to participate. If eligible, they will be contacted by our study team with further instructions on how to complete the survey and the blood collection after vaccination. Eligibility criteria are: 18+, receiving maintenance hemodialysis, English-speaking and has the intention to be vaccinated. Patients with prior diagnosis of COVID-19 can participate.
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