A drug that may benefit some patients admitted to hospital with Covid-19 pneumonia has been identified by researchers.
Led by the Universities of Birmingham and University Hospitals Birmingham NHS Foundation Trust, the Catalyst trial tested namilumab (IZN-101) as a potential treatment for patients who are receiving usual care.
They also had high levels in their blood of a marker of inflammation known as C reactive protein (CRP).
Levels of this protein increase when there is inflammation in the body, and research indicates elevated levels of CRP are a potential early marker to predict risk for severity of coronavirus.
An antibody already in late-stage trials to treat rheumatoid arthritis – UK based bio-pharmaceutical company Izana Bioscience’s namilumab – targets a protein which is naturally secreted by immune cells in the body.
However, in uncontrolled levels it is thought to be a key driver of the dangerous lung inflammation seen in Covid patients.
Our research has provided important proof-of-concept evidence that namilumab reduces inflammation in hospitalised patients with Covid-19 pneumoniaDr Ben Fisher
The trial, carried out in collaboration with the University of Oxford and funded by the Medical Research Council, was conducted between June 2020 and February 2021.
It involved patients aged over 16 with Covid-19 pneumonia either being treated on a ward or Intensive Care Unit (ICU) at nine NHS hospitals across the UK.
Fifty-four patients in the study were receiving usual care – steroids and oxygen or ventilation, depending on the severity of disease – and 57 patients given usual care as well as a single intravenous dose of 150mg of namilumab.
As well as Covid-19 pneumonia, all study participants had increased levels of CRP.
Researchers found there was a 97% probability of CRP being reduced over time in those given namilumab when compared with usual care alone.
After 28 days the study also showed there were fewer deaths and more discharges from hospital or ICU in those who had been given the drug 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, by day 28 11% (six) were still in hospital, compared to 20% (11) in the usual care group.
Of those in the namilumab group, 11% (six) patients died compared to 19% (10) who died in the usual care group by day 28.
According to the researchers, the probability of discharge at day 28 was 64% in the usual care cohort, compared to 77% in the namilumab cohort.
Of those in ICU, probability of discharge at day 28 was 47% in the usual care group, compared to 66% in the namilumab cohort.
Dr Ben Fisher, co-chief investigator of the Catalyst trial at the University of Birmingham’s Institute of Inflammation and Ageing, and consultant rheumatologist at University Hospitals Birmingham NHS Foundation Trust (UHB), said: “Our research has provided important proof-of-concept evidence that namilumab reduces inflammation in hospitalised patients with Covid-19 pneumonia.
“However, our sample size is too small for a definitive assessment of clinical outcomes and further studies are required for this, as well as to understand better the population that may benefit most.
“Our results may not generalise to hospitalised patients without evidence of pneumonia or raised CRP or patients not requiring hospitalisation.
“It is important, therefore, that namilumab is now prioritised for further Covid-19 research in a much larger national Phase III clinical trial.”
The team also tested a second drug called infliximab (CT-P13) which is 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.
The findings are published in The Lancet Respiratory Medicine.