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临床试验/NCT04359849
NCT04359849已完成不适用

Sequencing and Tracking of Phylogeny in COVID-19 Study

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 5,602 人开始时间: 2020年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,602
试验地点
1
主要终点
Number of whole genome sequences for the SARS-CoV-2 virus from viral RNA samples

研究概览

简要总结

The Investigators plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus

详细描述

The current Covid-19 pandemic has caused significant strain on the health care system, and an unprecedented Governmental response to stem the spread of the disease through social distancing and self-isolation. Covid-19 is a pneumonia-like severe acute respiratory syndrome (SARS) caused by a virus, SARS-CoV-2, with similarity to the SARS virus responsible for a worldwide outbreak in 2002. Due to the original SARS outbreak, a large body of genomic data exists for SARS coronaviruses, allowing researchers to understand how the new virus SARS-CoV-2 has evolved to be so virulent in humans.

Whilst testing kits have been designed to target specific genes in the viral RNA, whole genome sequencing of the virus offers increased scope to track the epidemiology of the virus. In addition, through the use of current sequencing technology available from Oxford Nanopore Technologies (ONT), genome scanning can be performed in real time and allow for identification of specific viral variants within patient samples. As the pandemic continues to spread, understanding the evolution of the virus and its spread across the globe will help researchers to begin to predict the future spread of the virus, estimate the number of worldwide cases, and aid in the development of epidemiological models for estimating a potential end point to the pandemic crisis. In addition, the ability to track mutations in real time allows researchers access to a large body of data to explore in order to identify potential targets for cures and vaccines. These data will also feed into the design of RNA-based therapeutic targets and diagnostics using patented array technology.

In this project, the investigators aim to use Nanopore-based sequencing technology to assemble viral genomes from patients who have presented to Portsmouth Hospital NHS Trust (PHT) in the Wessex region with symptoms of Covid-19. PHT, has containment level 3 (CL3) facilities within their Microbiology Department required for inactivation of the virus and extraction of viral RNA, and has recently begun testing of potential Covid-19 patients. Viral RNA samples from patients who show positive results will be selected for sequencing using Nanopore sequencing technology. Whole genome sequences will be compared using phylogenetic analysis to identify the spread of the virus within the local area, will be analysed in the context of anonymised patient level data to look for trends in the adaptation of the virus, and will be compared with a global database of such sequences to help develop global maps of transmission.

As part of the COVID-19 Genomics UK Consortium (COG-UK), the investigators will contribute sequencing data to the consortium which will monitor changes in the virus on a national scale to understand how the virus is mutating and spreading and whether different strains are emerging

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have undergone successful testing for Covid-19
  • Have sufficient viral RNA remaining for research analysis following testing for Covid-19

排除标准

  • Insufficient viral RNA remains following testing for Covid-19

结局指标

主要结局

Number of whole genome sequences for the SARS-CoV-2 virus from viral RNA samples

时间窗: 2 years

Generated using Nanopore-based whole genome sequencing techniques

次要结局

  • Transmission rates of the SARS-CoV-2 virus(2 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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