The CATALYST Trial tested the rheumatoid arthritis treatment namilumab as a potential therapeutic to treat patients who are hospitalised with COVID-19 pneumonia and receiving 'usual' care, but who also have high levels in their blood of a protein called CRP, whose levels rise when there is inflammation in the body. Higher levels of CRP have been found to be a potential early marker to predict risk for severity of COVID-19.
Namilumab, produced by the UK-based bio-pharmaceutical company Izana Bioscience's, is an antibody that targets a 'cytokine' which is naturally secreted by immune cells in the body but, at uncontrolled levels, is believed to be a key driver of the excessive and dangerous lung inflammation seen in COVID-19 patients.
The CATALYST Trial is a collaboration between the Universities of Birmingham and Oxford and is supported by the NIHR Oxford Biomedical Research Centre (BRC). The Oxford arm of the study is led by Professor Duncan Richards of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, and Dr Matt Rowland of the Nuffield Department of Clinical Neurosciences.
Between June 2020 and February 2021 recruited patients aged over 16 with COVID-19 pneumonia either being treated on a ward or Intensive Care Unit (ICU) at nine NHS hospitals, including and Oxford University Hospitals (OUH) NHS Foundation Trust.
The study findings, published in The Lancet Respiratory Medicine, showed that there was a 97% probability of CRP being reduced over time in those given a single dose of namilumab, when compared with usual care alone. The patients were monitored, and after 28 days the study also showed there were fewer deaths and more discharges from hospital or ICU in those who had been given namilumab compared to those receiving usual care alone. By day 28, 78% (43) of the patients receiving namilumab were discharged from hospital or ICU, compared to 61% (33) of the patients given usual care. In the namilumab group, 11% (6) were still in hospital by day 28, compared to 20% (11) in the usual care group. Of those in the namilumab group, 11% (6) patients died compared to 19% (10) who died in the usual care group by day 28.
While these findings provide important proof-of-concept evidence that namilumab reduces inflammation in hospitalised COVID-19 patients, the sample size is small. Larger-scale clinical trials are required to obtain a definitive assessment of clinical outcomes, as well as to understand better the population that may benefit most.
The Oxford researchers led the trial of a second potential drug treatment, called infliximab, which is currently used as a treatment for inflammatory conditions. They found that infliximab was not more effective than usual care, with just a 15% probability of CRP being reduced.