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NCT04633915 Clinical Trial

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

Covid19 Clinical Trial

— COV-HD  

Official title:
A Comparison of Antibody Response Against SARS-CoV-2 in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04633915
Other study ID # COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 26, 2020
Est. completion date July 18, 2021

Study information
Verified date August 2021
Source Saint Petersburg State University, Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date July 18, 2021
Est. primary completion date July 18, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Saint-Petersburg State University Hospital Saint Petersburg

Sponsors (1)
Lead Sponsor Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti-SARS-COV-2 IgG level 16 weeks
Secondary Proportion of people with detectable Anti-SARS-COV-2 IgG in study groups Day 1, weeks 8, 16
Secondary Anti-SARS-COV-2 IgG level 8 weeks
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