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

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.

Study Overview

• Status: Completed
• Conditions: Covid19

Detailed 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?

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients attending sohag university hospital and have recent COVID -19 infection

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID19 IGg
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IBR#S20-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No