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NCT04483622 Clinical Trial

Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients

Covid19 Clinical Trial

— COVID-19  

Official title:
Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04483622
Other study ID # IBR#S20-133
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 12, 2020
Est. completion date December 25, 2021

Study information
Verified date May 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to detect the evidence on the immune response following acute SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after infection for both symptomatic and asymptomatic patients.

Description:

A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab specimens. For the study, serum samples of the 30 patients will be collected and will be investigated for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples will be collected after that for 6 months later; one serum sample tested every month for 6 months after. The following questions will be addressed:- 1. What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2? 2. How long is the duration of detection of serum IgG antibodies and antibody titres over time following infection with SARS-CoV-2?

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date December 25, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 90 Years
Eligibility Inclusion Criteria: - patients with recent COVID- 19 infection(2 weeks after the second negative RT-PCR assay) Exclusion Criteria: - patients on immune-suppressive therapy - patients with immunological disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary rising titre of IGg antibodies it's expected to have COVID-19 antibodies within 1month of infection the antibody titre expected to rise the fall to a lower levels first month
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