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@article{Wilkinson:2020:10.1186/s13063-020-04584-9,
author = {Wilkinson, T and Dixon, R and Page, C and Carroll, M and Griffiths, G and Ho, L-P and De, Soyza A and Felton, T and Lewis, KE and Phekoo, K and Chalmers, JD and Gordon, A and McGarvey, L and Doherty, J and Read, RC and Shankar-Hari, M and Martinez-Alier, N and OKelly, M and Duncan, G and Walles, R and Sykes, J and Summers, C and Singh, D},
doi = {10.1186/s13063-020-04584-9},
journal = {Trials},
pages = {1--3},
title = {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: a structured summary of a study protocol for a randomised controlled trial},
url = {http://dx.doi.org/10.1186/s13063-020-04584-9},
volume = {21},
year = {2020}
}

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TY  - JOUR
AB  - ObjectivesStage 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 designACCORD 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.ParticipantsThe study will include hospitalised adult patients (≥18 years) with confirmed SARS-CoV-2 infection, the virus that causes COVID-19, that clinically meet Grades 3 (hospitalised – mild disease, no oxygen therapy), Grades 4 (hospitalised, oxygen by mask or nasal prongs) and 5 (hospitalised, non-invasive ventilation or high flow oxygen) of the WHO Working Group on the Clinical Characteristics of COVID-19 9-point category ordinal scale.Participants will be recruited from England, Northern Ireland, Wales and Scotland.Intervention and comparatorComparator is current standard of care (SoC) for the treatment
AU  - Wilkinson,T
AU  - Dixon,R
AU  - Page,C
AU  - Carroll,M
AU  - Griffiths,G
AU  - Ho,L-P
AU  - De,Soyza A
AU  - Felton,T
AU  - Lewis,KE
AU  - Phekoo,K
AU  - Chalmers,JD
AU  - Gordon,A
AU  - McGarvey,L
AU  - Doherty,J
AU  - Read,RC
AU  - Shankar-Hari,M
AU  - Martinez-Alier,N
AU  - OKelly,M
AU  - Duncan,G
AU  - Walles,R
AU  - Sykes,J
AU  - Summers,C
AU  - Singh,D
DO  - 10.1186/s13063-020-04584-9
EP  - 3
PY  - 2020///
SN  - 1745-6215
SP  - 1
TI  - 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: a structured summary of a study protocol for a randomised controlled trial
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-020-04584-9
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04584-9
UR  - http://hdl.handle.net/10044/1/83896
VL  - 21
ER  -

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