Testing Remdesivir in Hospitalized Adult Patients with Tick-Borne Encephalitis to Measure Effects on Brain Cell Damage

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What is this study about?

This study examines Tick-Borne Encephalitis, which is an infection caused by a virus transmitted through tick bites that affects the brain and nervous system. The study will test whether remdesivir, an antiviral medication, can help reduce damage to nerve cells in patients with this infection. Participants will receive either remdesivir or placebo through an intravenous infusion, which means the medication is given directly into a vein. An additional substance called mannitol, which belongs to a group called electrolytes, will also be used as part of the infusion solution. The purpose of the study is to evaluate whether remdesivir can reduce nerve cell injury during the infection, as measured by a substance in the blood called neurofilament light chain.

The treatment period will last up to 10 days, with participants receiving a daily dose of up to 200 milligrams of the medication. The total amount of medication given over the treatment period will not exceed 1100 milligrams. During the study, various tests and assessments will be performed at different time points, including blood samples, thinking and memory tests, questionnaires about fatigue and quality of life, and neurological examinations. Some participants may also provide samples of cerebrospinal fluid, which is the liquid surrounding the brain and spinal cord, as well as urine and saliva samples.

Participants will be followed for up to one year after starting treatment. During this time, they will undergo cognitive testing to assess memory, learning, attention, and thinking skills at weeks 12, 26, and 52. The study will also measure fatigue levels, pain scores, overall health status, and various biological markers in blood and other body fluids. Additional tests will examine the presence of the virus, antibody responses, and other factors that might influence how well the treatment works. The study will compare results between those receiving remdesivir and those receiving placebo to determine if the medication is effective in treating this infection.

1 Treatment period

Upon joining the study, treatment will begin while hospitalized. The treatment will start within 7 days from hospital admission.

Treatment will be administered through intravenous infusion, which means the medication will be delivered directly into a vein.

The study medication is either remdesivir or placebo. A placebo is an inactive substance that looks identical to the actual medication. This is a double-blind study, meaning neither the treating physician nor the patient will know which treatment is being received.

The treatment duration will be between 5 to 10 days, depending on the medical condition and clinical response.

The medication contains mannitol and electrolytes as additional components.

2 Day 1 assessments

On the first day of treatment, several assessments will be performed.

Blood samples will be collected to measure neurofilament light chain, which is a protein that indicates nerve cell damage.

Additional blood samples may be collected to measure GFAP, another protein related to brain cell function.

If a lumbar puncture (spinal tap) is performed, fluid from around the spinal cord may be collected for analysis.

A Visual Analogue Scale assessment will be completed, which involves rating symptoms on a scale to measure their severity.

3 Day 5 assessments

On the fifth day of treatment, blood samples will be collected again to measure neurofilament levels and other markers.

If a lumbar puncture is performed, spinal fluid may be collected for analysis.

Another Visual Analogue Scale assessment will be completed.

If treatment continues beyond 5 days, additional assessments may be performed on the last day of treatment.

4 Week 4 follow-up

Four weeks after treatment begins, a follow-up visit will be scheduled.

Blood samples will be collected to measure neurofilament levels, which is the primary outcome of the study.

A cognitive screening test called MoCA will be performed to assess memory and thinking abilities.

The Fatigue Severity Scale questionnaire will be completed to assess tiredness levels.

A health questionnaire called SF-36 will be completed to assess overall quality of life.

If a lumbar puncture is performed, spinal fluid may be collected for analysis.

5 Week 12 follow-up

Twelve weeks after treatment begins, another follow-up visit will be scheduled.

Blood samples will be collected to measure neurofilament and other markers.

Comprehensive cognitive testing will be performed using a digital test battery. These tests assess memory, learning ability, attention, information processing speed, and decision-making abilities.

The Fatigue Severity Scale questionnaire will be completed again.

The SF-36 health questionnaire will be completed.

A neurological examination will be performed to assess nerve and brain function.

If a lumbar puncture is performed, spinal fluid may be collected for analysis.

6 Week 26 follow-up

Twenty-six weeks (approximately 6 months) after treatment begins, a follow-up visit will be scheduled.

Comprehensive cognitive testing will be performed again using the digital test battery.

The Fatigue Severity Scale questionnaire will be completed.

The SF-36 health questionnaire will be completed.

7 Week 52 follow-up

Fifty-two weeks (one year) after treatment begins, the final follow-up visit will be scheduled.

Blood samples will be collected to measure neurofilament and other markers.

Comprehensive cognitive testing will be performed again using the digital test battery.

The Fatigue Severity Scale questionnaire will be completed.

The SF-36 health questionnaire will be completed.

This visit marks the end of participation in the study.

Who Can Join the Study?

You need to be admitted to the hospital at the time of screening
You must have symptoms that suggest TBE (Tick-Borne Encephalitis, which is a viral infection of the brain and nervous system caused by tick bites)
You must have been admitted to the hospital no more than 7 days before starting the study treatment
You must have a positive test result showing anti-TBEV IgM (special proteins in your blood or spinal fluid that indicate recent infection with the tick-borne encephalitis virus) or detectable TBEV RNA (genetic material of the virus) in your blood, CSF (cerebrospinal fluid, which is the liquid surrounding your brain and spinal cord), or urine
You must be at least 18 years old
You must provide written consent to take part in the trial

Who Cannot Join the Study?

The study information provided does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in this study, the research team will need to review your individual medical situation to determine if you are eligible to participate
General factors that often prevent participation in clinical trials may include having certain other medical conditions, taking medications that could interfere with the study treatment, or having allergies to the study medication
For this specific trial, exclusion criteria (reasons you cannot join) have not been detailed in the available information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Karolinska University Hospital	Solna	Sweden
Sankt Gorans Sjukhus	Stockholm	Sweden
Malarsjukhuset Eskilstuna	Eskilstuna	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Ukocowsgleawaaihglouy i Lhnsrjlpy	Linkoping	Sweden
Ucmlktgjnhwnkiivlxdjk Ökenxl	Orebro	Sweden
Susjrnpzyki Uyeaesvrdubiotihsysjk Öolxd	Gothenburg	Sweden
Ugnjxsl Uskgktjvxd Hrlvqfil	Uppsala	Sweden
Rptaid Vxwafckjw	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.04.2027

Trial locations

Investigated drugs:

Mannitol

Remdesivir is an antiviral medication that works by interfering with how viruses make copies of themselves. In this trial, it is being tested to see if it can help reduce brain and nerve damage in patients hospitalized with Tick-Borne Encephalitis, which is a viral infection that affects the brain and nervous system. The study will measure whether the medication can lower levels of a substance in the blood that indicates nerve damage.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in the study to compare against remdesivir to help determine if remdesivir is truly effective.

Tick-Borne Encephalitis – Tick-Borne Encephalitis is a viral infection transmitted to humans through the bite of infected ticks. The disease is caused by the TBE virus, which affects the central nervous system, including the brain and spinal cord. After a tick bite, the virus enters the bloodstream and can travel to the nervous system, causing inflammation. The infection typically begins with flu-like symptoms such as fever, headache, and body aches. As the disease progresses, it may lead to neurological symptoms including confusion, difficulty with coordination, memory problems, and impaired cognitive functions. Some patients experience long-lasting effects such as persistent fatigue, reduced processing speed, attention difficulties, and problems with learning and executive functions.

Trial ID:

2025-523476-23-00

Protocol code:

TREAT

Trial Phase:

Therapeutic exploratory (Phase II)

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Testing Remdesivir in Hospitalized Adult Patients with Tick-Borne Encephalitis to Measure Effects on Brain Cell Damage

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