Clinical trial NCT04495764: Registry of Sustained Immunity to COVID-19 Among ESKD Patients
Official title: Registry of Sustained Immunity to COVID-19 Among ESKD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Anti-SARS-CoV-2 Infection
Keywords: Immunoglobulin G
Immunoglobulin M
Lead sponsor: Davita Clinical Research
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 2315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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:

-

Primary outcomes:
measure: Anti-SARS-CoV-2 antibodies
timeFrame: Through study completion (5 visits), an average of 6 months
measure: Incidence and severity of COVID-19
timeFrame: Through study completion (5 visits), an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Victorville
country: United States
facility: DCR Victorville
state: California
city: Bridgeport
country: United States
facility: DCR Connecticut
state: Connecticut
city: Minneapolis
country: United States
facility: DCR Twin Cities
state: Minnesota
city: Las Vegas
country: United States
facility: DCR Las Vegas
state: Nevada
city: Bronx
country: United States
facility: DCR Bronx
state: New York
city: Canton
country: United States
facility: DCR Canton
state: Ohio
city: El Paso
country: United States
facility: DCR El Paso
state: Texas
city: Lewisville
country: United States
facility: DCR Lewisville
state: Texas
city: San Antonio
country: United States
facility: DCR San Antonio
state: Texas
city: San Antonio
country: United States
facility: DCR San Antonio
state: Texas
city: Norfolk
country: United States
facility: DCR Norfolk
state: Virginia
city: Milwaukee
country: United States
facility: DCR Milwaukee
state: Wisconsin
Study officials:
affiliation: Davita Clinical Research
name: Francesca Tentori, MD
role: PRINCIPAL_INVESTIGATOR
References: