BibTex format
@article{Hazell:2026,
author = {Hazell, L and Cooper, N},
journal = {BMJ Open},
title = {Multi-arm multi-stage randomised controlled trial of Inflammatory Signal Inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic},
year = {2026}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - Objectives: To determine the safety and efficacy of ruxolitinib and fostamatinib compared to standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia.Design: Adaptive multi-arm, multi-stage, randomised, open label trial (3-arm, 2-stage)Setting: Five hospitals in England between October 2020 and September 2022.Participants: Hospitalised patients (≥18 years) with COVID-19 pneumonia defined by a modified World Health Organisation (WHO) COVID-19 severity grade of 3 or 4. Interventions: Participants were randomly assigned 1:1:1 to receive ruxolitinib (10mg bd for 7 days then 5mg bd for 7 days), fostamatinib (150mg bd for 7 days then 100mg bd for 7 days) or SOC.Main outcome measures: Primary outcome was development of severe COVID-19 pneumonia (modified WHO severity grade ≥5) within 14 days of randomisation. Secondary outcomes included mortality, invasive and non-invasive ventilation, venous thromboembolism, duration of hospital stay, readmissions, inflammatory markers and serious adverse events (SAE). Results: At Stage 1, 181 patients were randomised, with 4 assessed as ineligible post-randomisation. Fostamatinib was stopped early for futility with 16 participants (27.6%, N=58) developing severe COVID-19 pneumonia compared to 15 (25.0%, N=60) in the SOC arm (adjusted odds ratio (aOR) compared to SOC: 1.12; 95% confidence interval (CI): 0.49 to 2.58; p=0.608). Ruxolitinib progressed to Stage 2 but the trial was stopped early due to slow recruitment. At the final analysis, 10 participants (16.1%, N=62) developed severe COVID-19 pneumonia in the ruxolitinib arm compared to 15 (24.6%, N=61) in the SOC arm (aOR: 0.63; 95% CI: 0.25 to 1.57; p=0.161). Four (7.4%) participants in the fostamatinib arm, none in the ruxolitinib arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported serious adverse event and were numerically higher in the fostamatinib (10, 17.2%) an
AU - Hazell,L
AU - Cooper,N
PY - 2026///
SN - 2044-6055
TI - Multi-arm multi-stage randomised controlled trial of Inflammatory Signal Inhibitors (MATIS) for patients hospitalised with COVID-19 pneumonia during the UK pandemic
T2 - BMJ Open
ER -