In a previous blog, Altea announced the start of recruiting in Switzerland for a clinical trial investigating the potential of the monoclonal antibody Temelimab for the treatment of fatigue and cognitive impairment in patients with Long COVID. The study is sponsored by GeNeuro SA and supported by the Swiss government.
Temelimab has previously shown anti-neurodegenerative benefits by targeting a protein (HERV-W-Env) that has been associated with autoimmune diseases (e.g., multiple sclerosis). This protein has also been found in some people affected by Long COVID, potentially explaining Cognitive Impairments and Fatigue symptoms. The study is a randomized controlled clinical trial in which eligible patients are randomized to receive Temelimab treatment or placebo (inactive drug) once a month for six months. Neuropsychological tests are conducted to evaluate the effect on Cognitive Impairment and Fatigue and outcomes such as anxiety and depression scores, quality of life, safety and tolerability of Temelimab versus placebo will be analyzed.
The recruitment period of the study is now extended to end of July 2023.
Patients can currently enroll at five different sites across Switzerland:
- Basel REHAB Clinic for Neurorehabilitation and Paraplegiology
- Inselspital Bern University Hospital
- Geneva University Hospital
- Cantonal Hospital of Graubünden
- Valais Hospital, Valais Romand hospital center
you are interested in participating, you are >18 years old, and you suffer from Fatigue and Cognitive Impairment symptoms in the context of Long COVID, you can register for the study till end of July 2023 (see Infoboxes for eligibility criteria and contact information).
In an update of the inclusion criteria the following criteria were changed:
- Patients with symptoms still occurring >12 weeks post diagnosis can be included.
- A SARS-CoV-2 infection can be confirmed by a positive diagnostic test (reverse transcriptase polymerase chain reaction (RT-PCR), validated SARS-CoV-2 antigen, or other molcular diagnostic assays and an appropriate test sample (nasopharyngeal, nasal, oropharyngeal, or saliva) or a confirmed SARS‑CoV-2 nucleocapsid or membrane antibody test associated to a medical report documenting the date of COVID-19 clinical diagnostic.
Updated eligibility criteria: all patients with symptoms still occurring >12 weeks post diagnosis are eligible; diagnosis needs to be confirmed by a positive diagnostic test or a medical report.
The study aims to involve 200 patients across all participating sites (Switzerland, Italy, Spain). After the final data collection, results will be processed, however, we will have to wait for those a bit more. If Temelimab proves to be safe and effectively reduces Fatigue and Cognitive Impairment symptoms, this would be a great advancement for Long COVID treatment.
Discuss this potential treatment option in the Altea Community
Join the discussions about Temelimab treatment, the study, and the recruitment process with the Altea Community if you would like to learn more.
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