Waxing and Waning of Serum SARS CoV-2-IgG Level in COVID-19 Exposed Population

NCT ID: NCT04568850

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-02-28

Brief Summary

This study will define the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered and those who were previously undiagnosed but were seropositive. These subjects will be followed for four months to evaluate the levels of antibodies in these people.

Detailed Description

Since December 2019, cases of unexplained pneumonia have occurred in Wuhan City, Hubei Province, subsequent virus isolation and whole-genome sequencing (accession#: MN908947) confirmed that it is an acute respiratory infection caused by new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . Coronaviruses are enveloped, non-segmented, single-positive-stranded RNA viruses with round or oval particles and a diameter of 50-200 nm. Coronavirus subfamily is divided into four genera: α, β, γ and δ according to serotype and genomic characteristics. The SARS-CoV-2 belongs to the genus β which has been confirmed to be highly infectious by research.

The four major structural proteins of coronavirus are the spike surface glycoprotein (S), small envelope protein (E), matrix protein (M), and nucleocapsid protein (N). The spike protein (S) of coronavirus is a type I transmembrane glycoprotein and mediates the entrance to human respiratory epithelial cells by interacting with cell surface receptor angiotensin-converting enzyme 2 (ACE2), the S protein contains distinct functional domains near the amino (S1) and carboxy (S2) termini, the peripheral S1 portion can independently bind cellular receptors while the integral membrane S2 portion is required to mediate fusion of viral and cellular membranes . The nucleocapsid protein (N) forms complexes with genomic RNA, interacts with the viral membrane protein during virion assembly and plays a critical role in enhancing the efficiency of virus transcription and assembly The seropositivity rate of both IgM and IgG responses after onset and recovery of disease, and in the context of both N protein and S protein has not been clarified. The kinetics of antibody responses in critical cases or ICU patients has not been reported, and no studies have suggested whether antibody response is associated with disease prognosis

Conditions

Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Plasma IgG levels

Plasma IgG levels of subjects who tested reactive for IgG SARS CoV-2 antibodies will be monitored every month for 4 months for IgG levels

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Subjects testing reactive for SARS CoV 2 IgG antibodies

Exclusion Criteria

• Subjects testing nonreactive for SARS CoV-2 IgG antibodies

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Amina Asif

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amina Asif, MPhilMicro

Role: PRINCIPAL_INVESTIGATOR

Lahore General Hospital

Locations

Lahore General Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Lahore General Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Amina Asif, MPhilMicro

Role: CONTACT

aminasif79@gmail.com

+92 300 5009929

M.Irfan Malik, FCPS

Role: CONTACT

Facility Contacts

Amina Asif, MBBS. MPhil

Role: primary

Irafn Malik, MBBS, FCPS, FRCP

Role: backup

M.Irfan Malik, FCPS

Role: primary

drmirfanmalik@hotmail.com

+ 92 333

Other Identifiers

LGH007

Identifier Type: -

Identifier Source: org_study_id