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SARS-COV-2 Characterisation Study [COVID-19]

  • Research type

    Research Study

  • Full title

    A dose finding human experimental infection study in healthy subjects using a GMP-produced SARS-COV-2 wild type strain

  • IRAS ID

    292098

  • Contact name

    Chris Chiu

  • Contact email

    c.chiu@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Eudract number

    2020-005415-52

  • Duration of Study in the UK

    1 years, 4 months, 24 days

  • Research summary

    Screening Protocol:
    The aim of this screening protocol is to assess volunteers for their potential eligibility to participate in a dose finding human experimental infection study in healthy subjects using a GMP produced SARS-CoV-2 wild type strain.
    Recruitment will be done through a number of channels:
    • Approved advertising, including social medial
    • hVIVO volunteer database
    • Referral
    • Organic search, i.e. where the volunteer has learned of this study by doing a Google search or through friends or family rather than due to any advertising Following Research Ethics Committee approval of the full study, screened subjects who confirm their willingness to participate in the SARS-CoV-2 human infection challenge characterization study will be invited to consider the study-specific PIS-ICF and enter the final study consenting process.
    The number of subjects who are to be recruited will depend on specific sample-size requirements for the SARS-CoV-2 human infection characterization study.

    Research protocol:
    This is a dose optimisation study in healthy adults aged 18-30 who will be experimentally inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in the majority of challenged individuals with minimal or no illness, providing data on the course of COVID-19 and the immune response to SARS-CoV-2 infection. This will establish an optimised dose and study design that will then be used to evaluate the efficacy of treatment and vaccine candidates in follow-on trials.

    This research is funded by the UK Government’s department for Business, Energy and Industrial Strategy and is being sponsored by Imperial College London and conducted by hVIVO Services Ltd. Screening and follow up visits will take place at hVIVO's QMB facility and quarantine will take place at the royal free hospital.

  • REC name

    Specialist Adhoc REC

  • REC reference

    20/UK/0002

  • Date of REC Opinion

    16 Feb 2021

  • REC opinion

    Further Information Favourable Opinion