Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06510426

Early Interferon-beta Treatment for West-Nile Virus Infection

Led by Tel-Aviv Sourasky Medical Center · Updated on 2024-07-23

100

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Early Interferon-beta Treatment for West-Nile Virus Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have clinical symptoms compatible with West Nile virus infection such as fever, headache, flaccid paralysis, or encephalopathy
  • Diagnosis confirmed by positive anti-WNV IgM antibodies or WNV PCR from serum, urine, or cerebrospinal fluid
  • Patients older than 70 years of age at higher risk for severe disease
  • Patients with neuroinvasive disease including flaccid paralysis or encephalitis, regardless of age
  • Immunocompromised patients of any age, including those with hematologic malignancies, recent chemotherapy, stem cell or organ transplant, use of immunosuppressants, or immunodeficiency disorders
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years old
  • Pregnant women
  • Hypersensitivity to natural or recombinant interferon beta
  • Decompensated liver disease
  • Patients with neuroinvasive disease who show spontaneous improvement over more than 2 days and have a Modified Rankin Scale score below 4
  • More than 8 days since onset of neurological symptoms in immunocompetent patients
  • More than 10 days since onset of neurological symptoms in immunocompromised patients unless new encephalitis symptoms develop
  • Patients receiving active chemotherapy or with concurrent severe viral infections

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Actively Recruiting

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Research Team

D

David Hagin, MD PhD

CONTACT

D

Dania Dror, B.Nutr; MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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