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Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19. (COV-HD)

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: NCT04633915
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Ekaterina Parshina, Saint Petersburg State University, Russia

Study Description
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Brief Summary:

This is prospective cohort study aimed to compare antibody response against SARS-CoV-2 in dialysis patients and non-dialysis-dependent volunteers.

The research hypothesis is that dynamic of IgG antibodies against SARS-CoV-2 will differ in two groups.

To determine whether there is a statistically significant interaction between factors "group" and "time" on the titer of IgG antibodies against SARS-CoV-2, a two-way repeated measures ANOVA will be used.


Condition or disease
Dialysis Covid19

Detailed Description:
In both groups level of IgG antibodies against SARS-CoV-2 will be measured at the Day 1 (10 weeks from the date of first symptoms), Weeks 8 and 16 from the Day 1.
Study Design
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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.
Actual Study Start Date : November 26, 2020
Actual Primary Completion Date : July 18, 2021
Actual Study Completion Date : July 18, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Dialysis
Patients with CKD stage 5, treated with maintenance hemodialysis
Healthy
Volunteers who are not dialysis-dependent


Outcome Measures
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Primary Outcome Measures :
  1. Anti-SARS-COV-2 IgG level [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups [ Time Frame: Day 1, weeks 8, 16 ]
  2. Anti-SARS-COV-2 IgG level [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples Without DNA
Serum samples for determination of antibodies

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Patient ≥ 18 years old who were diagnosed with SARS-CoV-2 infection confirmed by PCR or strongly suspected on computed tomography within 10 weeks prior enrollment.

Main group include patients with chronic kidney disease stage 5, receiving hemodialysis as a renal replacement therapy.

The another group include volunteers who are not dialysis-dependent.

Criteria

Inclusion Criteria:

  • Age 18 years or older
  • SARS-CoV-2 infection within 10 weeks prior enrollment, confirmed by PCR or strongly suspected on computed tomography
  • Providing informed consent

Exclusion Criteria:

  • Refusal to provide informed consent
Contacts and Locations
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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): NCT04633915


Locations
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Russian Federation
Saint-Petersburg State University Hospital
Saint Petersburg, Russian Federation, 190103
Sponsors and Collaborators
Saint Petersburg State University, Russia
More Information
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Responsible Party: Ekaterina Parshina, Principal investigator, MD, Saint Petersburg State University, Russia
ClinicalTrials.gov Identifier: NCT04633915    
Other Study ID Numbers: COVID
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Ekaterina Parshina, Saint Petersburg State University, Russia:
antibodies
IgG
CKD
hemodialysis
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases