Antibody Responses in Asymptomatic Close Contacts of COVID-19 Patients and Their Implications
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measure level of Abs in asymptomatic close contacts of COVID 19 patients.
研究概览
简要总结
After several cases of pneumonia with an unfamiliar etiology were observed at the end of 2019, the National Health Commission of China released more details about the epidemic in early 2020. The pathogen was identified as a novel coronavirus and named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as it has a phylogenetic similarity to SARS-CoV. Since then, SARS-CoV-2 has spread rapidly and the resulting coronavirus disease 2019 (COVID-19) has been declared a public health emergency of international concern (PHEIC) by the World Health Organization (WHO).
SARS-CoV-2 is highly contagious, and there has not yet been any vaccine or effective treatment that has received approval. So, the best solution for controlling the pandemic will be the simultaneous application of preventive methods, sensitive diagnostic approaches, and using current available drugs, while still developing novel treatments.
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.
详细描述
The SARS-CoV-2 belongs to the genus β which has been confirmed to be highly infectious by research. (https://www.who.int/emergencies/ diseases/novel-coronavirus-2019/situation-reports).
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 diagnosis of COVID-19 is dependent mainly on clinical characteristics, CT imaging and a few laboratory tests. Although some symptoms and laboratory parameters have indicative values in confirmed patients, they are not unique to SARSCoV-2 infection. The most used and reliable test for diagnosis of COVID-19 has been the RT-PCR test performed using nasopharyngeal swabs. A variety of RNA gene targets are used by different manufacturers, with most tests targeting 1 or more of the envelope (env), nucleocapsid (N), spike (S), RNA-dependent RNA polymerase (RdRp), and ORF1 genes .
Spread of the COVID-19 global pandemic highlights the urgent need to develop effective treatments or vaccines against SARS-CoV-2 infection. The identification of novel antibodies to neutralize the virus is one of the approaches to fight COVID-19 . In particular, detect an antibody against the SARS-CoV-2 spike protein by building on knowledge about the existing structure of SARS-CoV-2 and learnings from previous SARS antibody generations. Potent neutralizing antibodies often target the receptor interaction site in S1, disabling receptor interactions. The so-called spike protein of 2019-nCoV is used by the virus to dock to human cells. By targeting the protein, to prevent the infection.
COVID-19 patients developed SARS-CoV-2-specific NAbs at the convalescent phase of infection (SARS-CoV-2 NAbs were unable to cross-reactive with SARS-CoV virus). SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •close contacts of confirmed COVID-19 patients, apparently healthy
排除标准
- •symptomatic close contacts, any close contacts with malignant tumor, stroke, cardiac, respiratory, Gastrointestinal, and renal diseases or any organ dysfunction.
结局指标
主要结局
Measure level of Abs in asymptomatic close contacts of COVID 19 patients.
时间窗: one day
serum level of antiSARS-CoV-2 IgG, IgM
次要结局
未报告次要终点
研究者
Aliae AR Mohamed Hussein
Professor of Pulmonology
Assiut University
