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NCT04871945 Clinical Trial

Protective Antibody Level After COVID-19 Vaccination Among Patients Under Hemodialysis

Covid19 Clinical Trial

Official title:
Evaluation of Protective Antibody Production After COVID-19 Vaccination Among Patients Under Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04871945
Other study ID # 2021-02-033
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2021
Est. completion date October 31, 2021

Study information
Verified date March 2021
Source Hanyang University Seoul Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate the level of neutralizing antibody against SARS-CoV-2 after COVID-19 vaccination in patients under hemodialysis. To this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date October 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The person who is vaccinated with ChAdOx1 (COVID-19 vaccine) - The person who agrees with the protocol of the study Exclusion Criteria: - Age < 18 years - Pregnants - Experience of COVID-19 infection

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA)
The antibody level will be measured by the above mentioned methods. The trial drugs are not used but the vaccine that included in National Immunization Program for COVID-19 in Korea will be used for the study.

Locations
Country Name City State
Korea, Republic of Hanyang University Seoul Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Hanyang University Seoul Hospital Seegene Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change in the level of neutralizing antibody against SARS-CoV-2 Day 0, 14, 28, 56, 91, 120
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