ACCORD: 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
Funder: BERGENBIO AS
Sponsor: UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST
CI: Dr Tom Wilkinson
Approval Date: 21 April 2020
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.
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 (CRF) network to enable the rapid development, conduct and reporting of clinical trials of candidate agents for the treatment of COVID-19. There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), the causative agent of COVID 19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID 19. The Master Protocol outlines the overall structure of the study, including the population, inclusion and exclusion criteria, randomisation scheme, primary, secondary, and exploratory outcomes, study design, statistical methodology, and planned analyses that are common for all candidate agents to be tested. The Master Protocol is structured such that multiple candidate agents from different pharmaceutical companies can be evaluated simultaneously. The plan is to add candidate agents as they are identified, and to remove therapies once they have completed their evaluation. The sub-protocols will outline the scientific rationale, eligibility, treatment schema, and other specifics for each candidate agent. Study centres will be located in the United Kingdom. Overall, it is estimated that approximately 12 centres and investigators will initially take part in the study. It is estimated that up to 1800 patients will participate in the overall study. Candidates: Bemcentinib, Medi3506, Acalabrutinib, Zilucoplan, Nebulised Heparin
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