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Lookup NU author(s): Professor James WasonORCiD, Dr Svetlana CherlinORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.Objectives To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia. Design Adaptive multiarm, multistage, randomised, open-label trial (three arm, two 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 WHO COVID-19 severity grade of 3 or 4. Interventions Participants were randomly assigned 1:1:1 to receive RUX (10 mg two times per day for 7 days then 5 mg two times per day for 7 days), FOS (150 mg two times per day for 7 days then 100 mg two times per day 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 (SAEs). Results At stage 1, 181 patients were randomised, with 4 assessed as ineligible post randomisation. FOS was stopped early for futility with 16 participants (27.6%, n=58) developing severe COVID-19 pneumonia compared with 15 (25.0%, n=60) in the SOC arm (adjusted odds ratio (aOR) compared with SOC: 1.12; 95% CI 0.49 to 2.58; p=0.608). RUX 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 RUX arm compared with 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 FOS arm, none in the RUX arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported SAE and were numerically higher in the FOS (10, 17.2%) and RUX (10, 16.1%) arms compared with SOC (7, 11.5%). Two unexpected serious adverse reactions occurred in the RUX arm only. Conclusions We found no evidence that FOS was superior to SOC for the treatment of COVID-19 pneumonia in patients requiring hospital admission. Due to early stopping, the trial was underpowered to establish RUX’s effect in this population. Further study is needed.
Author(s): Hazell L, Pillay C, Cornelius V, Phillips R, Charania A, Wason J, Cherlin S, Savic S, Whittington A, Neelakantan P, Collini P, Cook L, Willicome M, Milojkovic D, Kon OM, Youngstein T, Innes A, Thursz M, Cooke GS, Vergis N, Cooper N
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2026
Volume: 16
Issue: 2
Online publication date: 05/02/2026
Acceptance date: 18/12/2025
Date deposited: 24/02/2026
ISSN (electronic): 2044-6055
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bmjopen-2025-100583
DOI: 10.1136/bmjopen-2025-100583
Data Access Statement: Data are available upon reasonable request. Deidentified participant-level data (excluding free text fields) and supporting documentation (including the MATIS study protocol, Statistical Analysis Plan and data dictionary) can be made available on reasonable request from the corresponding author (https://profiles.imperial.ac.uk/n.cooper) for the purposes of scientific research including secondary analysis of the data or for individual participant meta-analysis with appropriate human research ethics approvals and data transfer agreements in place.
PubMed id: 41644167
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