Registry of Sustained Immunity to COVID-19 Among ESKD Patients

SARS-CoV-2 Infection Clinical Trial

— RePAiR  

Official title:

Registry of Sustained Immunity to COVID-19 Among ESKD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495764
• Other study ID #: 20-M-0044-00
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: February 12, 2021

Study information

• Verified date: May 2021
• Source: Davita Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2315
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Anti-SARS-CoV-2 Infection
• Communicable Diseases
• Infection
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
United States	DCR Connecticut	Bridgeport	Connecticut
United States	DCR Bronx	Bronx	New York
United States	DCR Canton	Canton	Ohio
United States	DCR El Paso	El Paso	Texas
United States	DCR Las Vegas	Las Vegas	Nevada
United States	DCR Lewisville	Lewisville	Texas
United States	DCR Milwaukee	Milwaukee	Wisconsin
United States	DCR Twin Cities	Minneapolis	Minnesota
United States	DCR Norfolk	Norfolk	Virginia
United States	DCR San Antonio	San Antonio	Texas
United States	DCR San Antonio	San Antonio	Texas
United States	DCR Victorville	Victorville	California

Sponsors (1)

Lead Sponsor	Collaborator
Davita Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

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