Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.

NCT ID: NCT04633915

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-26

Study Completion Date

2021-07-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dialysis Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dialysis

Patients with CKD stage 5, treated with maintenance hemodialysis

No interventions assigned to this group

Healthy

Volunteers who are not dialysis-dependent

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Petersburg State University, Russia

OTHER

Sponsor Role lead

Responsible Party

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Ekaterina Parshina

Principal investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint-Petersburg State University Hospital

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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COVID

Identifier Type: -

Identifier Source: org_study_id

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