Clinical trial • Phase IV • Infectious Disease

Remdesivir for Tick-borne encephalitis

Phase IV trial of Remdesivir for Tick-borne encephalitis.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Tick-borne encephalitis
Trial Stage
Phase IV
Drug Modality
Small molecule|Small molecule

Key dates

Initial CTIS Submission Date
17-12-2025
First CTIS Authorization Date
12-02-2026

Trial design

Randomised, placebo: electrolytes (mannitol) intravenous infusion; product maxdailydoseamount 1000 ml, maxtotaldoseamount 10000 ml, max treatment period 10 days. (placebo role described as electrolytes / mannitol).-controlled Phase IV trial in Sweden.

Randomised
Yes
Comparator
Placebo: ELECTROLYTES (Mannitol) intravenous infusion; product maxDailyDoseAmount 1000 ml, maxTotalDoseAmount 10000 ml, max treatment period 10 days. (Placebo role described as ELECTROLYTES / Mannitol).
Target Sample Size
126
Trial Duration For Participant
364

Eligibility

Recruits 126 No vulnerable populations selected (isVulnerablePopulationSelected: false); inclusion criterion: "6. The patient has given their written consent to participate in the trial"; non-Swedish speaking persons are excluded ("2. Non-Swedish speaking")..

Pregnancy Exclusion
5. Pregnancy (verified by urine pregnancy test at screening)
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false); inclusion criterion: "6. The patient has given their written consent to participate in the trial"; non-Swedish speaking persons are excluded ("2. Non-Swedish speaking").

Inclusion criteria

  • {"criterion_text":"- 1.\tNeed of hospitalization at screening\n- 2.\tClinically suspected TBE according to ECDC definition\n- 3.\tHospitalization ≤ 7 days prior to start of study treatment. The 7-day period is counted as 7 full calendar days prior to the day of IMP initiation, regardless of time of hospitalization or treatment start. E.g., admission Apr 10 at 08:00 allows IMP initiation up until Apr 17 23:59.\n- 4.\tPositive anti-TBEV IgM in blood or CSF, or detectable TBEV RNA in a clinical specimen (blood, CSF or urine) according to local test results\n- 5.\t≥18 years old\n- 6.\tThe patient has given their written consent to participate in the trial"}

Exclusion criteria

  • {"criterion_text":"- 1.\tHypersensitivity to the active substances or ingredients of remdesivir or against any residues according to SmPC.\n- 2.\tNon-Swedish speaking\n- 3.\tOther contraindication to remdesivir treatment\n- 4.\tChronic kidney disease stadium 4 and 5\n- 5.\tPregnancy (verified by urine pregnancy test at screening)\n- 6.\tUnable to comply with protocol requirements\n- 7.\tBefore TBE-diagnosis, diagnosed with dementia or other chronic cognitive dysfunction.\n- 8.\tTreatment or disease which, according to the investigator, can affect treatment or trial results."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- S-NfL level at Week 4 after initiation of treatment, analyzed comparatively between the remdesivir and placebo arms.","definition_or_measurement_approach":"Measured by serum neurofilament light chain (S-NfL) levels at Week 4; analysed comparatively between remdesivir and placebo arms."}

Secondary endpoints

  • {"endpoint_text":"- Comprehensive cognitive testing targeting memory and learning, working memory, processing speed, attention and executive functions, operationalized as a composite cognitive score and also analyzed as individual test scores. Measured at week 12, 26 and 52, after treatment start, using a CE-marked digital neurocognitive test battery, analyzed comparatively between treatment arms. Cognitive screening (MoCA) performed in early phase (week 4).\n- Fatigue Severity Scale measured at week 4, 12, 26 and 52, after treatment start, analyzed comparatively between treatment arms.\n- Visual Analogue Scale (VAS) scores at Day 1, 5 and, if longer duration of treatment, also on the last day of treatment. Analyzed comparatively between treatment arms.\n- Detailed methods to record AEs and SAEs are described in section 9.3. The definition of SAEs is included in this study protocol in section 9.1.\n- •\tNumber of hospital-free days alive during study participation. •\tMortality at End of Trial •\tDays on advanced respiratory support from Start to End of Trial •\tNeurological status (46) at Week 12 compared to at start of treatment. •\tPatient questionnaire (SF-36) assessing self-reported health-related quality of life, at week 4, 12, 26 and 52. Analyzed comparatively between treatment arms.\n- Time from hospitalization to start of treatment in relation to NfL/GFAP and/or the composite cognitive score at Week 4 in the remdesivir arm.\n- Number of days of remdesivir treatment (5, 6, 7, 8, 9 or 10 days) in relation to NfL/GFAP and/or the composite cognitive score at Week 4 in the remdesivir arm.\n- Time from anamnestic fever onset to treatment initiation in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Number and timing of previous TBE-, Yellow Fever -or Japanese Encephalitis vaccinations in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Sex, anamnestic height and weight (BMI), comorbidities, age in relation to NfL/GFAP the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Concomitant medication use in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Tick-borne co-infections confirmed by blood analysis in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- S-NfL levels at time points other than Week 4 (i.e., Day 1, Day 5, Week 4, Week 12, and Week 52), analyzed comparatively between treatment arms.\n- CSF neurofilament concentrations before and after treatment initiation (i.e., Day 1, Day 5, Week 4 and Week 12), analyzed comparatively between treatment arms.\n- GFAP levels in blood and/or CSF before and after treatment initiation (i.e., Day 1, Day 5, Week 4, Week 12, and Week 52), analyzed comparatively between treatment arms.\n- Concentrations of remdesivir and GS-441524 in CSF, blood, and/or urine on Day 5 in relation to NfL/GFAP and/or the composite cognitive score at Week 4 in the remdesivir arm.\n- Anti-TBE (IgG, IgM, and/or IgA) and neutralizing antibody concentrations in CSF, blood and/or saliva (before and/or after treatment initiation) in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms\n- Concentrations of anti–type I interferon autoantibodies in CSF and/or blood in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Detection and/or quantification of TBEV RNA in CSF, blood, and saliva (before and/or after treatment initiation) in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Host genomic variants in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.\n- Host proteomic signatures in relation to NfL/GFAP and/or the composite cognitive score at Week 4, analyzed comparatively between treatment arms.","definition_or_measurement_approach":"Endpoints are measured at specified time points and analysed comparatively between treatment arms. Examples: cognitive testing via CE-marked digital neurocognitive test battery (weeks 12, 26, 52; MoCA at week 4); Fatigue Severity Scale (weeks 4,12,26,52); VAS at Day 1,5 and end of treatment; S-NfL and CSF NfL/GFAP at listed time points; remdesivir and GS-441524 concentrations in CSF/blood/urine on Day 5; antibody and RNA assays; genomic and proteomic analyses as specified."}

Recruitment

Planned Sample Size
126
Recruitment Window Months
21
Consent Approach
Written informed consent required from the patient (adult ≥18). Inclusion criterion: "6. The patient has given their written consent to participate in the trial". Non-Swedish speaking persons are excluded ("2. Non-Swedish speaking"). Subject information and consent documents are listed (L1_Information till forsoksperson_TREAT_huvudstudie and variants) in Swedish.

Geography

Total Number Of Sites
14
Total Number Of Participants
126

Sweden

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
10
Number Of Sites
14
Number Of Participants
126

Sites

Site Name
Universitetssjukhuset i Linköping
Department Name
Infektionskliniken
Principal Investigator Name
Johanna Sjövall
Principal Investigator Email
Johanna.sjowall@liu.se
Contact Person Name
Johanna Sjövall
Contact Person Email
Johanna.sjowall@liu.se
Site Name
Universitetssjukhuset Örebro
Department Name
Infektionskliniken
Principal Investigator Name
Sara Cajander
Principal Investigator Email
sara.cajander@regionorebrolan.se
Contact Person Name
Sara Cajander
Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Infektionsektionen
Principal Investigator Name
Katarina Brodin-Hertzell
Principal Investigator Email
Katarina.brodinhertzell@capiostgoran.se
Contact Person Name
Katarina Brodin-Hertzell
Site Name
Malarsjukhuset Eskilstuna
Department Name
Infektionskliniken
Principal Investigator Name
Markus Kalén
Principal Investigator Email
Markus.kalen@regionsormland.se
Contact Person Name
Markus Kalén
Contact Person Email
Markus.kalen@regionsormland.se
Site Name
Västmanlands sjukhus Västerås
Department Name
Infektionskliniken
Principal Investigator Name
Anders Krifors
Principal Investigator Email
anders.krifors@regionvastmanland.se
Contact Person Name
Anders Krifors
Site Name
Soedersjukhuset AB
Department Name
Infektionskliniken
Principal Investigator Name
Karolin Falconer
Principal Investigator Email
karolin.falconer@regionstockholm.se
Contact Person Name
Karolin Falconer
Site Name
Skaraborg Hospital-Vaestra Goetalandsregionen
Department Name
Infektionskliniken
Principal Investigator Name
Kenny Brandström
Principal Investigator Email
Kenny.brandstrom@vgregion.se
Contact Person Name
Kenny Brandström
Contact Person Email
Kenny.brandstrom@vgregion.se
Site Name
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
Department Name
Infektionskliniken
Principal Investigator Name
Miriam Frankal
Principal Investigator Email
Miriam.frankal@vgregion.se
Contact Person Name
Miriam Frankal
Contact Person Email
Miriam.frankal@vgregion.se
Site Name
Danderyds Sjukhus AB
Department Name
Infektionskliniken
Principal Investigator Name
Ida Söderqvist
Principal Investigator Email
ida.soderqvist@regionstockholm.se
Contact Person Name
Ida Söderqvist
Site Name
NU Hospital Group-Vaestra Goetalandsregionen
Department Name
Infektionskliniken
Principal Investigator Name
Sara Morgardt
Principal Investigator Email
sara.morgardt@vgregion.se
Contact Person Name
Sara Morgardt
Contact Person Email
sara.morgardt@vgregion.se
Site Name
Centralsjukhuset Karlstad
Department Name
Infektionskliniken
Principal Investigator Name
Staffan Tevell
Principal Investigator Email
staffan.tevell@regionvarmland.se
Contact Person Name
Staffan Tevell
Site Name
Uppsala University Hospital
Department Name
Infektionskliniken
Principal Investigator Name
Fredrik Sund
Principal Investigator Email
fredrik.sund@akademiska.se
Contact Person Name
Fredrik Sund
Contact Person Email
fredrik.sund@akademiska.se
Site Name
Karolinska University Hospital
Department Name
Medicinsk enhet Infektionssjukdomar
Principal Investigator Name
Hedvig Glans
Principal Investigator Email
hedvig.glans@regionstockholm.se
Contact Person Name
Hedvig Glans
Site Name
Sahlgrenska Universitetssjukhuset Östra
Department Name
Infektionskliniken
Principal Investigator Name
Malin Veje
Principal Investigator Email
malin.veje@vgregion.se
Contact Person Name
Malin Veje
Contact Person Email
malin.veje@vgregion.se

Sponsor

Primary sponsor

Full Name
Region Stockholm – SLSO
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
REMDESIVIR
Active Substance
Remdesivir
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised (existing marketing authorisation for new indication exploration)
Maximum Dose
max daily 200 mg, max total 1100 mg
Investigational Product Name
ELECTROLYTES
Active Substance
Mannitol
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
max daily 1000 ml, max total 10000 ml

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