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SPIKE-1 [COVID-19]

  • Research type

    Research Study

  • Full title

    A Randomised Phase II trial in early COVID-19, assessing use of camostat by blocking SARS-CoV-2 Spike protein-initiated membrane fusion

  • IRAS ID

    282538

  • Contact name

    Kevin Dhaliwal

  • Contact email

    Kev.Dhaliwal@ed.ac.uk

  • Sponsor organisation

    Cancer Research UK, Centre for Drug Development

  • Eudract number

    2020-002110-41

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    This is a phase II/III randomised , multi-centre, prospective, open label, community-based clinical trial. The trial aims to recruit patients who test positive for COVID-19 but who have mild disease and therefore can treat their symptoms in the community. Patients (50 years or older) who seek testing and have a confirmed positive test result will be invited to enrol in the trial. The trial has a pilot phase and then a continuation phase. Patients will be randomised into a treatment arm (camostat tablets) or control arm (best supportive care). Patients will be called daily at home for 14 days by the clinical trial team to collect symptoms and record the general well-being of the patient. The primary aim of this trial is to determine if camostat can reduce the clinical progression of COVID-19 and therefore the need for hospital admimission and supplemental oxygen. Secondary aims include collection of patient reported health status, severity of symptoms and biological markers of the virus. As the understanding of COVID-19 develops and improves, the inclusion criteria may be adapted to support the trial outcomes. Patients will be recruited through various settings which may include primary care ‘COVID-19 hub’ clinics, COVID-19 community-based testing centres or other clinical environments.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    20/NW/0278

  • Date of REC Opinion

    18 Jun 2020

  • REC opinion

    Further Information Favourable Opinion