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OpenTrials
Completed

NCT Number: NCT04633915

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anti-SARS-COV-2 IgG level

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Acronym: COV-HD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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