Registry of Sustained Immunity to COVID-19 Among ESKD Patients

Completed

• Conditions: Anti-SARS-CoV-2 Infection; SARS-CoV-2 Infection

• Registration Number: NCT04495764
• Lead Sponsor: Davita Clinical Research

Brief 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 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 Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-03
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2315

Inclusion Criteria

• 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.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of COVID-19	Through study completion (5 visits), an average of 6 months
Anti-SARS-CoV-2 antibodies	Through study completion (5 visits), an average of 6 months

Trial Locations

Locations (11)

DCR Canton; 🇺🇸 Canton, Ohio, United States

DCR El Paso; 🇺🇸 El Paso, Texas, United States

DCR San Antonio; 🇺🇸 San Antonio, Texas, United States

DCR Lewisville; 🇺🇸 Lewisville, Texas, United States

DCR Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

DCR Victorville; 🇺🇸 Victorville, California, United States

DCR Bronx; 🇺🇸 Bronx, New York, United States

DCR Norfolk; 🇺🇸 Norfolk, Virginia, United States

DCR Connecticut; 🇺🇸 Bridgeport, Connecticut, United States

DCR Twin Cities; 🇺🇸 Minneapolis, Minnesota, United States

DCR Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States