One of the largest planned studies into long-COVID has passed an important milestone as efforts to tackle what is a major unmet medical need are stepped up.
The bio-pharma firm GeNeuro has recruited 203 patients across 14 clinical centres in Switzerland, Spain and Italy to its phase 2 trial evaluating temelimab against the condition.
The randomised, placebo-controlled, biomarker-based, Phase 2 clinical trial assessing the effect of the treatment with temelimab on the clinical course of these symptoms.
GeNeuro is focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases such as MS, ALS and long-COVID.
All enrolled patients receive 6 intravenous infusions of temelimab or placebo over 24 weeks. The clinical endpoints will assess the efficacy and the safety of the treatment with temelimab on the improvement in fatigue and cognitive impairment measures.
The recruitment of the trial has already demonstrated that the expression of the pathogenic W-ENV protein, triggered by the SARS-CoV-2 infection, may continue long after the acute phase has been resolved.
Over one third of the patients presenting long-COVID syndromes who were screened were positive to the presence of W-ENV in their blood.
W-ENV is suspected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralising anti-W-ENV-antibody.
Prof. Idris Guessous, head of the division of primary care medicine at the Geneva University Hospitals and principal investigator of the study, said: “Long-COVID is proving to be a major unmet medical need as patients who are suffering from its impairing syndromes are often helpless. The patient response to the study as well as their dedication to participation has been very encouraging.
“We hope that this trial targeting the pathogenic W-ENV protein will result rapidly into a personalised medicine approach, identifying and treating patients who may benefit from the therapy.”
Prof. David Leppert, CMO of GeNeuro, said: “W-ENV has been shown to be pro-inflammatory and pathogenic to nervous system cells. Its neutralisation with temelimab, a highly specific antibody with an excellent tolerability profile, aims to improve symptoms of fatigue and cognitive impairment.
“The trial will establish how much this neutralisation impacts the clinical symptoms affecting long-COVID patients and, if substantial enough, temelimab could become a first disease-modifying therapy in this underserved new indication.”
Last month Imperial College London reported that tens of thousands of people in England may have lasting symptoms from COVID‐19 more than a year after infection.
The findings came from a representative sample of more than a quarter of a million people in England surveyed as part of the REACT study, who self-reported their symptoms and the impact of COVID-19 on their health and quality of life.
The work, led by researchers at Imperial College London, found that while the vast majority of people recovered from infection within two weeks, a significant proportion of the group (7.5%) reported persistent symptoms lasting 12 weeks or more (Long COVID), and 5% reported symptoms lasting more than a year.
The most common lasting symptoms were mild fatigue, difficulty thinking or concentrating and joint pains. But other persistent symptoms reported included loss or change of sense of smell or taste, shortness of breath, severe fatigue, chest tightness or pain, and poor memory.
People were more likely to report symptoms for a long time after their initial infection if they were female, had severe initial symptoms, were infected earlier in the pandemic, or had pre-existing health conditions.
Some of these symptoms were also quite often reported by people who did not have previous COVID-19.
However, mental health and health-related quality of life were worse among participants with ongoing persistent symptoms post-COVID compared with those who had never had COVID-19 or had recovered.
