Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry of Sustained Immunity to COVID-19 Among ESKD Patients (RePAiR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495764
Recruitment Status : Active, not recruiting
First Posted : August 3, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Davita Clinical Research

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.


Condition or disease
SARS-CoV-2 Infection Anti-SARS-CoV-2 Infection

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 2504 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Sustained Immunity to COVID-19 Among ESKD Patients
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021



Primary Outcome Measures :
  1. Anti-SARS-CoV-2 antibodies [ Time Frame: Through study completion (5 visits), an average of 6 months ]
  2. Incidence and severity of COVID-19 [ Time Frame: Through study completion (5 visits), an average of 6 months ]

Biospecimen Retention:   Samples With DNA
Baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495764


Locations
Layout table for location information
United States, California
DCR Victorville
Victorville, California, United States, 92394
United States, Connecticut
DCR Connecticut
Bridgeport, Connecticut, United States, 06606
United States, Minnesota
DCR Twin Cities
Minneapolis, Minnesota, United States, 55404
United States, Nevada
DCR Las Vegas
Las Vegas, Nevada, United States, 89128
United States, New York
DCR Bronx
Bronx, New York, United States, 10461
United States, Ohio
DCR Canton
Canton, Ohio, United States, 44718
United States, Texas
DCR El Paso
El Paso, Texas, United States, 79925
DCR Lewisville
Lewisville, Texas, United States, 75057
DCR San Antonio
San Antonio, Texas, United States, 78215
DCR San Antonio
San Antonio, Texas, United States, 78230
United States, Virginia
DCR Norfolk
Norfolk, Virginia, United States, 23502
United States, Wisconsin
DCR Milwaukee
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Davita Clinical Research
Layout table for additonal information
Responsible Party: Davita Clinical Research
ClinicalTrials.gov Identifier: NCT04495764    
Other Study ID Numbers: 20-M-0044-00
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Davita Clinical Research:
Immunoglobulin G
Immunoglobulin M
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases