Cognitive impairment and Fatigue: recruitment is open for a new clinical study

Cognitive impairment and Fatigue: recruitment is open for a new clinical study

A new clinical study testing a treatment to reduce Fatigue and Cognitive impairments started in Switzerland. Recruitment is open: participate now!

It is already quite established that Long COVID patients frequently report Fatigue and Cognitive impairments, such as brain fog, memory loss, difficulty with spoken and written language. These symptoms prevent patients from continuing with their daily and professional activities, hence it is of great urgency to find treatments that can help reduce, if not remove, those symptoms.

A few months ago, in a previous blog, Altea discussed the developments in research, also mentioning a study that would have started, with the aim of testing a treatment to reduce Fatigue. The time has now come: the study to investigate a monoclonal antibody, called Temelimab, sponsored by GeNeuro SA and supported by the Swiss government has started. Participants who are willing to participate can join the study.

A study investigating a monoclonal antibody, Temelimab, against Fatigue and Cognitive impairments has started in Switzerland.

How does the study work?

The study is a randomized controlled clinical trial. This means that after screening and recruitment, eligible patients will be randomly assigned (that is, patients cannot choose in which group they will be) to one of two groups: Group 1) will receive the Temelimab treatment, and Group 2) will receive a placebo (inactive drug). The study lasts 6 months, and the treatment or the placebo will be administered once a month, for a total of six times.

During this period, neuropsychological tests will be conducted to understand whether the treatment has a positive effect in reducing Fatigue and Cognitive impairments. Further, other outcomes will be measured, such as anxiety and depression scores, functional impairment, quality of live, as well as safety and tolerability of Temelimab in Long COVID patients. During the study, patients will be constantly under medical care and supervision.

The goal of the study is to investigate the efficacy of Temelimab, when treating patients with Long COVID who had a severe acute Covid-19 infection (but not admitted in intensive care treatment). Temelimab is treatment that has been previously used to slow down the progress of Multiple Sclerosis.

Why Temelimab?

The treatment Temelimab, a monoclonal antibody, targets a protein (HERV-W-Env) that has been shown to be associated with some autoimmune disorders (such as Multiple Sclerosis) and that could explain the Cognitive impairments and Fatigue. This protein has also been found in some people affected by Long COVID. If this treatment works, Long COVID patients would have a treatment to reduce or eliminate these symptoms.

Recruitment is now open: the study sites are looking for participants!

The study is currently conducted in different sites in Switzerland:

 

Recruitment is now open

The sites are currently recruiting patients. If you would like to participate, you are 18+, and you suffer from Long Covid, in particular with Fatigue and cognitive symptoms, you can register for the study (see Infobox for more information). You will receive an appointment for a first meeting, where the eligibility criteria will be examined, and then, if eligible, you will be able to participate in the study.

The study started end of August 2022, and the final data collection is expected to be done by end of March 2023. For the results, we will have to wait a bit more. However, if the Temelimab shows to be safe and effective, this would mean a great step in the direction of Long COVID treatment.

Discuss about Temelimab in the Altea Community

In the Altea Community there are discussions about the study and the recruitment. If you would like to discuss more about it, please join!

Eligibility Criteria
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Contacts for more information and recruitment
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