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@article{Fisher:2022:10.1016/S2213-2600(21)00460-4,
author = {Fisher, BA and Veenith, T and Slade, D and Gaskell, C and Rowland, M and Whitehouse, T and Scriven, J and Parekh, D and Balasubramaniam, MS and Cooke, G and Morley, N and Gabriel, Z and Wise, MP and Porter, J and McShane, H and Ho, L-P and Newsome, PN and Rowe, A and Sharpe, R and Thickett, DR and Bion, J and Gates, S and Richards, D and Kearns, P and CATALYST, investigators},
doi = {10.1016/S2213-2600(21)00460-4},
journal = {The Lancet Respiratory Medicine},
pages = {255--266},
title = {Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial.},
url = {http://dx.doi.org/10.1016/S2213-2600(21)00460-4},
volume = {10},
year = {2022}
}

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TY  - JOUR
AB  - BACKGROUND: Dysregulated inflammation is associated with poor outcomes in COVID-19. We aimed to assess the efficacy of namilumab (a granulocyte-macrophage colony stimulating factor inhibitor) and infliximab (a tumour necrosis factor inhibitor) in hospitalised patients with COVID-19, to prioritise agents for phase 3 trials. METHODS: In this randomised, multicentre, multi-arm, multistage, parallel-group, open-label, adaptive, phase 2, proof-of-concept trial (CATALYST), we recruited patients (aged ≥16 years) admitted to hospital with COVID-19 pneumonia and C-reactive protein (CRP) concentrations of 40 mg/L or greater, at nine hospitals in the UK. Participants were randomly assigned with equal probability to usual care or usual care plus a single intravenous dose of namilumab (150 mg) or infliximab (5 mg/kg). Randomisation was stratified by care location within the hospital (ward vs intensive care unit [ICU]). Patients and investigators were not masked to treatment allocation. The primary endpoint was improvement in inflammation, measured by CRP concentration over time, analysed using Bayesian multilevel models. This trial is now complete and is registered with ISRCTN, 40580903. FINDINGS: Between June 15, 2020, and Feb 18, 2021, we screened 299 patients and 146 were enrolled and randomly assigned to usual care (n=54), namilumab (n=57), or infliximab (n=35). For the primary outcome, 45 patients in the usual care group were compared with 52 in the namilumab group, and 29 in the usual care group were compared with 28 in the infliximab group. The probabilities that the interventions were superior to usual care alone in reducing CRP concentration over time were 97% for namilumab and 15% for infliximab; the point estimates for treatment-time interactions were -0·09 (95% CI -0·19 to 0·00) for namilumab and 0·06 (-0·05 to 0·17) for infliximab. 134 adverse events occurred in 30 (55%) of 55 patients in the namilumab group compared with
AU  - Fisher,BA
AU  - Veenith,T
AU  - Slade,D
AU  - Gaskell,C
AU  - Rowland,M
AU  - Whitehouse,T
AU  - Scriven,J
AU  - Parekh,D
AU  - Balasubramaniam,MS
AU  - Cooke,G
AU  - Morley,N
AU  - Gabriel,Z
AU  - Wise,MP
AU  - Porter,J
AU  - McShane,H
AU  - Ho,L-P
AU  - Newsome,PN
AU  - Rowe,A
AU  - Sharpe,R
AU  - Thickett,DR
AU  - Bion,J
AU  - Gates,S
AU  - Richards,D
AU  - Kearns,P
AU  - CATALYST,investigators
DO  - 10.1016/S2213-2600(21)00460-4
EP  - 266
PY  - 2022///
SN  - 2213-2600
SP  - 255
TI  - Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial.
T2  - The Lancet Respiratory Medicine
UR  - http://dx.doi.org/10.1016/S2213-2600(21)00460-4
UR  - https://www.ncbi.nlm.nih.gov/pubmed/34922649
UR  - https://www.sciencedirect.com/science/article/pii/S2213260021004604?via%3Dihub
UR  - http://hdl.handle.net/10044/1/93592
VL  - 10
ER  -

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