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临床试验/NCT04568850
NCT04568850Unknown不适用

Waxing and Waning of Serum SARS CoV 2 IgG Level: A Prospective Study

Lahore General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Serum IgG for SARS CoV 2 will be monitored

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects testing reactive for SARS CoV 2 IgG antibodies

排除标准

  • Subjects testing nonreactive for SARS CoV-2 IgG antibodies

结局指标

主要结局

Serum IgG for SARS CoV 2 will be monitored

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amina Asif

Assistant Professor

Lahore General Hospital

研究点 (1)

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