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The University of Southampton
Southampton Clinical Trials Unit

ACCORD

Trial Name

ACCORD

Description

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.

Objectives

Stage 1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage.

Stage 2: To confirm the efficacy of candidate agents selected on the basis of evidence from Stage 1 in patients hospitalised with COVID-19 in an expansion stage.

Trial Design

ACCORD is a seamless, Phase 2, adaptive, randomised controlled platform study, designed to rapidly test candidate agents in the treatment of COVID-19. Designed as a master protocol with each candidate agent being included via its own sub-protocol, initially randomising equally between each candidate and a single contemporaneous SoC arm (which can adapt into 2:1). Candidate agents currently include bemcentinib, MEDI3506, acalabrutinib, zilucoplan and nebulised heparin. For each candidate a total of 60 patients will be recruited in Stage 1. If Stage 1 provides evidence of efficacy and acceptable safety the candidate will enter Stage 2 where a total of approximately 126 patients will be recruited into each study arm sub-protocol. Enrollees and outcomes will not be shared across the Stages; the endpoint, analysis and sample size for Stage 2 may be adjusted based on evidence from Stage 1. Additional arms may be added as new potential candidate agents are identified via candidate agent specific sub-protocols.

Trial Status

Open to recruitment.

Population

ACCORD will include several different potential treatments. These include new and existing anti-viral drugs, drugs which affect the immune system and drugs which target inflammatory molecules. The patient population will vary depending on the treatment.

Other

EudraCT 2020-001736-95, registered 28th April 2020.

Trial Team

The ACCORD steering committee is chaired by Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton with  Professor Gareth Griffiths, SCTU as a member. It also includes a team of clinical and scientific experts, representatives of the trial sponsor and the UKRI, and representatives from the trial sites and delivery group.

Contact Information

Email: [email protected]

Essential Documentation

All documentation for the ACCORD trial can be accessed via www.accord-trial.org

Other Media

All documentation for the ACCORD trial can be accessed via www.accord-trial.org

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