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

Completed

• Conditions: Dialysis; Covid19

• Registration Number: NCT04633915
• Lead Sponsor: Saint Petersburg State University, Russia

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.

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 Timeline

• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-18
• Study Start: 2020-11-26
• Primary Completion: 2021-07-18
• Study Completion: 2021-07-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-SARS-COV-2 IgG level	16 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups	Day 1, weeks 8, 16
Anti-SARS-COV-2 IgG level	8 weeks

Trial Locations

Locations (1)

Saint-Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russian Federation