Early Interferon-beta Treatment for West-Nile Virus Infection

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

West Nile virus (WNV) is a mosquito-borne virus which in majority of cases causes only self-limited disease. Despite that, in minority of cases (\ 0.5%) it can infect the brain and cause severe and even life-threatening disease (neuroinvasive disease). Recent study has shown that up to 40% of WNV patients who develop neuroinvasive disease, have antibodies against Interferons (anti-Type I interferon autoantibodies), which neutralizes interferons, and could explain the development of severe disease. The investigators therefore assume that early treatment with interferon beta (the type of interferon against which most patients do not have neutralizing antibodies) could prevent the development of severe neuroinvasive WNV disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ We aim to focus on three patients' populations:

• Patients older than 70 years of age, who are at higher risk for the presence of neutralizing anti-Type I IFN auto-antibodies, and therefore at higher risk for developing severe neuroinvasive disease. Only patients who fulfill the diagnostic criteria above will be included.

• Patients presenting with neuroinvasive WNV disease, including either flaccid paralysis or encephalitis, independent of their age, excluding a presentation consistent with isolated aseptic meningitis (headache, fever, 6th nerve palsy). Only patients who fulfill the diagnostic criteria above will be included.

• Immunocompromised patients at any age. Immunocompromised patients will be defined as patients with hematologic malignancy (treated or untreated); chemotherapy within previous 4 weeks, stem cell transplant recipient or solid organ transplant recipient; use of any immunosuppressant drug including prednisone greater than or equal to 20 mg/day within the previous 4 weeks; primary / acquired immunodeficiency disorder. Only patients who fulfill the diagnostic criteria above will be included.

Locations
Other Locations
Israel
Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
David Hagin, MD PhD
Davidha@tlvmc.gov.il
972524792296
Backup
Dania Dror, B.Nutr; MPH
Daniad@tlvmc.gov.il
97236974679
Time Frame
Start Date: 2024-07-14
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Active Treatment
Patients enrolled to participate in the Active Treatment arm will receive 3 subcutaneous injections of 44mcg Interferon b-1a (Rebif), given 48h hours apart.
Placebo_comparator: Placebo
Patients enrolled to participate in the placebo arm will receive 3 subcutaneous injections of normal saline, given 48h hours apart.
Sponsors
Leads: Tel-Aviv Sourasky Medical Center

This content was sourced from clinicaltrials.gov