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Antibody Response Against SARS-CoV-2 in Dialysis Patients During COVID-19 (COVCKD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367714
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Aarhus University Hospital
Central Jutland Regional Hospital
Aalborg University Hospital
Information provided by (Responsible Party):
Frank Mose, Region MidtJylland Denmark

Brief Summary:
Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020

Condition or disease
COVID Terminal Renal Insufficiency

Detailed Description:
Blood samples are collected every 14 days

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Antistof Respons Mod SARS-CoV-2 Hos Dialysepatienter i Forbindelse Med COVID-19
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021



Primary Outcome Measures :
  1. AAntibody response [ Time Frame: 1 year ]
    IgM and IgG against SARS-CoV-2


Biospecimen Retention:   Samples With DNA
Samples for determination of antibodies, cytokines, RNA and DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dilaysis patients on 3 Danish center in Jutland
Criteria

Inclusion Criteria:

  • Dialysis

Exclusion Criteria:

  • Not willing to give consent

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): NCT04367714


Contacts
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Contact: Frank Mose, MD +4528531257 frchri@rm.dk

Locations
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Denmark
Godstrup Hospital Recruiting
Herning, Denmark, 7400
Contact: Frank Mose    28531257    frchri@rm.dk   
Sponsors and Collaborators
Region MidtJylland Denmark
Aarhus University Hospital
Central Jutland Regional Hospital
Aalborg University Hospital
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Responsible Party: Frank Mose, MD PhD, Region MidtJylland Denmark
ClinicalTrials.gov Identifier: NCT04367714    
Other Study ID Numbers: FHM-1-2020
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frank Mose, Region MidtJylland Denmark:
COVID-19
CKD 5
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases