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

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

Remdesivir – Remdesivir is an antiviral medication that is given directly into the vein through an injection (intravenous administration) and is currently being studied in clinical trials for the treatment of Tick-Borne Encephalitis, a viral brain infection transmitted by tick bites. The medication works by blocking the virus's ability to copy itself inside human cells, specifically by interfering with the viral enzyme that helps the virus multiply. Remdesivir belongs to a class of drugs called antiviral agents and has been previously approved for treating other viral infections, and researchers are now investigating whether it can reduce brain and nerve damage caused by the Tick-Borne Encephalitis virus by measuring specific markers of nerve injury in the blood.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523476-23-00Protocol codeTREATEstimated enrolment126 patientsSponsorRegion Stockholm – SLSO

sourced from the EU Clinical Trials Register and site verification

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