Registry of Sustained Immunity to COVID-19 Among ESKD Patients

NCT ID: NCT04495764

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-02-12

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.

Conditions

SARS-CoV-2 Infection; Anti-SARS-CoV-2 Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Davita Clinical Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesca Tentori, MD

Role: PRINCIPAL_INVESTIGATOR

Davita Clinical Research

Locations

DCR Victorville

Victorville, California, United States

DCR Connecticut

Bridgeport, Connecticut, United States

DCR Twin Cities

Minneapolis, Minnesota, United States

DCR Las Vegas

Las Vegas, Nevada, United States

DCR Bronx

The Bronx, New York, United States

DCR Canton

Canton, Ohio, United States

DCR El Paso

El Paso, Texas, United States

DCR Lewisville

Lewisville, Texas, United States

DCR San Antonio

San Antonio, Texas, United States

DCR San Antonio

San Antonio, Texas, United States

DCR Norfolk

Norfolk, Virginia, United States

DCR Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

20-M-0044-00

Identifier Type: -

Identifier Source: org_study_id