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

NCT04633915 | Completed

• 1 other identifier: COVID
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis; Covid19

Keywords

antibodies; IgG; CKD; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Anti-SARS-COV-2 IgG level

  16 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Dialysis

Patients with CKD stage 5, treated with maintenance hemodialysis

Healthy

Volunteers who are not dialysis-dependent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal to provide informed consent

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for determination of antibodies

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 18, 2020
• Study Start: November 26, 2020
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

RU (1)