Study Detail

Clinical Characterisation Protocol (CCP) for Severe Emerging Infection

Clinical Characterisation Protocol for Severe Emerging Infection

Status: Open

Type: Observational

Funder: Wellcome Trust

Sponsor: University of Oxford

CI: Prof Malcolm Semple

IRAS-Number: 126600

CPMS-ID: 14152

Approval Date: 24 January 2020


New infectious agents, such as the SARS coronavirus, new strains of influenza, and HIV, continually appear and require new investigations to understand how the disease works and how it interacts with the person infected. There is an urgent need to conduct coordinated clinical research relating to the COVID-19 outbreak to learn more about the virus and to provide evidence to help decide treatments and to ensure an effective public health response. This study will provide rapid, coordinated clinical investigation of patients with confirmed COVID-19 infection. It will look at how the virus reproduces and is excreted by the body, how the body responds to infection and treatment over time and how the immune system responds. The study has been designed to ensure that as much data as possible is collected and shared rapidly in a format that can be easily added together, tabulated and analysed across many different settings globally. It is designed to be flexible to ensure the best acceptance by health care organisations. [COVID-19 amendment - 24/02/2020]


Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status. This study, while not a study of a medicine, may involve additional procedures (some minimally invasive), the retention of genetic material, collection of personal data and additional follow up. The ISARIC consortium is keen that this protocol serve as a generic template for adoption of this study in other countries and similar studies in the future. ISARIC also intend that this protocol and supporting documents can be used to support or run alongside future intervention studies. For these reasons we aim to fulfil the standards of consent required by Medicines for Human Use (Clinical Trials) Regulations 2004 and NHS NPSA NRES Guidance for Researchers & Reviewers (May 2009). This protocol as now amended is designed to enrol patients with proven infection by Influenza A/H5N1, A/H7N9, MERS-CoV, SARS-CoV-2, viral haemorrhagic fever, TBEV, any infection on the PHE/DHSC high consequence infection list (see PHE website), and any other pathogen of public health interest as yet unspecified.

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