- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04495764
Registry of Sustained Immunity to COVID-19 Among ESKD Patients (RePAiR)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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Victorville, California, Forenede Stater, 92394
- DCR Victorville
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06606
- DCR Connecticut
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- DCR Twin Cities
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
- DCR Las Vegas
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New York
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Bronx, New York, Forenede Stater, 10461
- DCR Bronx
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- DCR Canton
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Texas
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El Paso, Texas, Forenede Stater, 79925
- DCR El Paso
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Lewisville, Texas, Forenede Stater, 75057
- DCR Lewisville
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San Antonio, Texas, Forenede Stater, 78230
- DCR San Antonio
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San Antonio, Texas, Forenede Stater, 78215
- DCR San Antonio
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- DCR Norfolk
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- DCR Milwaukee
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
- 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.
Beskrivelse
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:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Anti-SARS-CoV-2 antibodies
Tidsramme: Through study completion (5 visits), an average of 6 months
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Through study completion (5 visits), an average of 6 months
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Incidence and severity of COVID-19
Tidsramme: Through study completion (5 visits), an average of 6 months
|
Through study completion (5 visits), an average of 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Francesca Tentori, MD, Davita Clinical Research
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20-M-0044-00
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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