Registry of Sustained Immunity to COVID-19 Among ESKD Pat... | NCT04495764

Studies
Registry of Sustained Immunity to COVID-19 Among ESKD Patients

NCT04495764

Sponsor

Davita Clinical Research

Status

Completed

Last Update Posted

May 27, 2021Actual

Enrollment

2,315Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2020Actual

Primary Completion Date

Feb 12, 2021Actual

Completion Date

Feb 12, 2021Actual

First Submitted Date

Jul 22, 2020

First Submission Date that Met QC Criteria

Jul 30, 2020

First Posted Date

Aug 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2021

Last Update Posted Date

May 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,315Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francesca Tentori, MD	Davita Clinical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DCR Victorville		Victorville	California	92394	United States
DCR Connecticut

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided