Study Detail

ACCORD

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

Status: Open

Type: Interventional

Funder: BERGENBIO AS

Sponsor: UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST

CI: Dr Tom Wilkinson

IRAS-Number: 282769

CPMS-ID: 45616

Approval Date: 21 April 2020

Description:

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

Study URL:

https://www.ACCORD-trial.org

Back to listing