Tick-Borne Encephalitis (TBE) Remdesivir Efficacy Assessment Trial (TREAT) – A phase 2 proof-of-concept, national, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy of remdesivir in adult patients hospitalized for TBE
This study, called TREAT, is investigating a medicine called remdesivir for adults who are in hospital because they have Tick-Borne Encephalitis, also known as TBE. TBE is a serious infection that can affect the brain and nervous system. The main goal is to see if remdesivir can help reduce the amount of brain damage, measured by a specific marker in the blood, compared to a placebo (a dummy drug). Researchers will also be looking at how well patients' memory, thinking, and overall health improve over time. Participants will receive either remdesivir or a placebo, along with supportive care like electrolytes. This is an important step to find better ways to treat TBE.
At a glance
What is this study about?
Tick-Borne Encephalitis (TBE) is a serious illness caught from tick bites that can cause inflammation of the brain and spinal cord. While there's a vaccine to prevent it, once someone gets TBE, treatment options are limited. This study, called TREAT, is looking at a medicine called remdesivir, which is already used for some other viral infections, to see if it could be helpful for TBE.
The main aim of the study is to find out if remdesivir can reduce brain damage in people hospitalised with TBE. We'll be measuring a specific substance in the blood that goes up when there's damage to nerve cells in the brain. If remdesivir can lower this substance, it would suggest the medicine is protecting the brain.
Beyond brain damage markers, the study will also look at many other aspects of a patient's health. This includes checking memory, thinking skills, how tired they feel, their overall quality of life, and if there are any serious side effects. By carefully comparing patients who receive remdesivir with those who receive a dummy drug (placebo), researchers hope to understand if this medicine could be a new and effective way to treat TBE.
Key takeaways
- This study is testing remdesivir for adults in hospital with TBE.
- It aims to see if remdesivir reduces brain damage and improves thinking skills.
- You'll either receive remdesivir or a placebo (dummy drug).
- Participation involves blood tests and thinking tests over one year.
- The study helps find better treatments for TBE.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
You would typically be considered for the study if you have been diagnosed with Tick-Borne Encephalitis and are currently in hospital because of it.
There might be other health conditions or medicines that would prevent you from joining, as the researchers need to make sure the study is safe and appropriate for everyone involved. Your doctor would check all the detailed requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Tick-Borne Encephalitis (TBE)?
- Are you currently in hospital for TBE?
- Are you able to attend follow-up appointments for a year?
What does participation involve?
If you join the study, you will either receive the study medicine, remdesivir, or a placebo (a dummy medicine that looks the same but contains no active drug). You'll also receive standard care like fluids and minerals (electrolytes) if needed. Because this is a 'double-blind' study, neither you nor your doctors will know whether you are getting remdesivir or the placebo, which helps make the results fair and accurate.
Your participation will involve several assessments over a year. This includes regular blood tests to check on the brain damage marker, detailed tests on your memory, thinking, and attention (using a special digital test), and questionnaires about how you feel, your fatigue, and your quality of life. You'll have these assessments at different points: at 4 weeks, 12 weeks, 26 weeks, and 52 weeks (a full year) after you start treatment. Medical staff will also carefully record any side effects you experience. The total duration of your participation will be about 52 weeks from when you start the treatment.
Potential risks and benefits
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Common questions
What is Tick-Borne Encephalitis (TBE)?
TBE is a serious infection spread by tick bites that can affect the brain and spinal cord, causing fever, headaches, vomiting, and sometimes more severe problems like confusion or fits.
What is remdesivir?
Remdesivir is a medicine that works against some viruses. This study is testing if it can also help people with TBE.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare how well the actual medicine works.
Will I know if I'm getting the actual medicine or the placebo?
No, neither you nor your doctors will know what you are receiving. This is called 'double-blind' and makes the study results more reliable.
How long will I be in the study?
If you join, you'll be part of the study for about one year after you start the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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