NCT04495764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

July 22, 2020

Last Update Submit

May 26, 2021

Conditions

Keywords

Immunoglobulin GImmunoglobulin M

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

DCR Victorville

Victorville, California, 92394, United States

Location

DCR Connecticut

Bridgeport, Connecticut, 06606, United States

Location

DCR Twin Cities

Minneapolis, Minnesota, 55404, United States

Location

DCR Las Vegas

Las Vegas, Nevada, 89128, United States

Location

DCR Bronx

The Bronx, New York, 10461, United States

Location

DCR Canton

Canton, Ohio, 44718, United States

Location

DCR El Paso

El Paso, Texas, 79925, United States

Location

DCR Lewisville

Lewisville, Texas, 75057, United States

Location

DCR San Antonio

San Antonio, Texas, 78215, United States

Location

DCR San Antonio

San Antonio, Texas, 78230, United States

Location

DCR Norfolk

Norfolk, Virginia, 23502, United States

Location

DCR Milwaukee

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Francesca Tentori, MD

    Davita Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

August 3, 2020

Study Start

July 20, 2020

Primary Completion

February 12, 2021

Study Completion

February 12, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations