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

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ClinicalTrials.gov Identifier: NCT04568850
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Amina Asif, Lahore General Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: Plasma IgG levels

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

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Waxing and Waning of Serum SARS CoV 2 IgG Level: A Prospective Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: 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

Outcome Measures
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Primary Outcome Measures :
  1. Serum IgG for SARS CoV 2 will be monitored [ Time Frame: 5 months ]
    Subjects testing reactive for SARS CoV 2 IgG antibodies will be followed for five months to see the levels of IgG SARS CoV 2


Biospecimen Retention:   Samples Without DNA
Plasma of the subjects will be saved,

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
subjects who suffered from COVID 19 and then had recovered and those who were previously undiagnosed but were seropositive.
Criteria

Inclusion Criteria:

  • Subjects testing reactive for SARS CoV 2 IgG antibodies

Exclusion Criteria:

  • Subjects testing nonreactive for SARS CoV-2 IgG antibodies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568850


Contacts
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Contact: Amina Asif, MPhilMicro +92 300 5009929 aminasif79@gmail.com
Contact: M.Irfan Malik, FCPS

Locations
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Pakistan
Lahore General Hospital Recruiting
Lahore, Punjab, Pakistan, 57000
Contact: Amina Asif, MBBS. MPhil         
Contact: Irafn Malik, MBBS, FCPS, FRCP         
Lahore General Hospital Recruiting
Lahore, Punjab, Pakistan, 5700
Contact: M.Irfan Malik, FCPS    + 92 333    drmirfanmalik@hotmail.com   
Sponsors and Collaborators
Lahore General Hospital
Investigators
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Principal Investigator: Amina Asif, MPhilMicro Lahore General Hospital
More Information
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Responsible Party: Amina Asif, Assistant Professor, Lahore General Hospital
ClinicalTrials.gov Identifier: NCT04568850    
Other Study ID Numbers: LGH007
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases