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ACCORD-2: Phase 2 study of multiple agents in COVID-19 patients [COVID-19] [UPH]

  • Research type

    Research Study

  • Full title

    ACCORD-2-001: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID 19 in Hospitalised Patients\nACCORD-2-002: Sub protocol for Candidate Agent: Bemcentinib

  • IRAS ID

    282769

  • Contact name

    Tom Wilkinson

  • Contact email

    T.Wilkinson@soton.ac.uk

  • Sponsor organisation

    University Hospital Southampton NHS Foundation Trust

  • Eudract number

    2020-001736-95

  • ISRCTN Number

    ISRCTN57085639

  • Clinicaltrials.gov Identifier

    Sub-protocol number for Bemcentinib, ACCORD-2-002

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    The ACCORD clinical trials program brings together expertise of the Southampton National Institute for Health Research Biomedical Research Centre (NIHR BRC), NIHR Health Protection Research Unit for Emerging and Zoonotic Diseases, NIHR Respiratory Translational Research Collaboration, NIHR Southampton Clinical Trials Unit, Pharmaceutical companies, IQVIA and the NIHR Clinical Research Facility network to enable the rapid development, conduct and reporting of clinical trials of possible treatments for COVID-19. This program is designed to rapidly assess lots of possible treatments. Study centres will be located in the United Kingdom. It is estimated that approximately 12 centres will initially take part in the study with up to 1800 patients in the overall study.Bemcentinib is currently being developed to treat different types of cancer, including leukaemia. It may block the COVID-19 virus from making extra copies of itself by lowering the ability of the virus to infect the linings of lungs and it has been shown to help the lungs defend against the virus. Bemcentinib is being developed by BerGenBio ASA and will be tested as a potential treatment for COVID-19 in 2 stages. Stage 1 will test how safe bemcentinib is when given with normal hospital treatment and whether it improves symptoms of COVID-19. The information gathered from Stage 1 will be used to see if bemcentinib should continue to be tested in Stage 2 of the study which will look at whether symptoms have improved, if care in the intensive care unit is needed, and survival and health status after recovery. Patients will be randomly given Bemcentinib with standard hospital treatment or Standard hospital treatment alone.Bemcentinib comes as a 100 mg capsule (a type of pill). It is taken by mouth once a day for up to 15 days or until discharge from the hospital (whichever is first). On the first 3 days patients will receive 4 capsules (400 mg total), for the next 12 days patients will receive 2 capsules (200 mg total). Stage 1 will include about 60 people. Stage 2 will include about 126. The treatment period will last up to 15 days but may be extended to 21 days if needed. The study will determine whether bemcentinib can lessen the symptoms of COVID-19 and/or shorten the time people with COVID-19 are ill.

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    20/SC/0201

  • Date of REC Opinion

    24 Apr 2020

  • REC opinion

    Favourable Opinion