Early treatment with interferon-beta for West Nile virus infection

Early Interferon-beta Treatment for West-Nile Virus Infection

This study is testing if giving interferon-beta early can help older patients with West Nile virus infection avoid severe symptoms like encephalitis or paralysis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tel-Aviv Sourasky Medical Center (Government)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Tel Aviv)
• Trial ID: NCT06510426 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of early treatment with interferon-beta in patients diagnosed with West Nile virus (WNV) infection, particularly those at risk of developing severe neuroinvasive disease. The study focuses on older patients and those presenting with neuroinvasive symptoms such as encephalitis or flaccid paralysis. By administering interferon-beta, which is not neutralized by autoantibodies in most patients, the trial aims to prevent the progression to severe disease. Diagnosis will be confirmed through serology or PCR testing for WNV.

Who should consider this trial

Good fit: Ideal candidates include patients over 70 years old or those presenting with neuroinvasive symptoms of WNV infection.

Not a fit: Patients with isolated aseptic meningitis or those without confirmed WNV infection will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of severe neuroinvasive disease caused by West Nile virus.

How similar studies have performed: While there is limited data on interferon-beta specifically for WNV, similar approaches using interferons for viral infections have shown promise in other contexts.

Eligibility criteria

Diagnosis of WNV infection will be based on the following:

1. Patients with clinical presentation suspected as compatible with WNV infection, with symptoms including elevated fever, headache or flaccid paralysis or fever with encephalopathy.

   And:
2. Positive anti-WNV IgM serology / WNV PCR from either serum, urine or CSF.

Inclusion criteria:

We aim to focus on three patients' populations:

1. 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.
2. 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.
3. 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.

Exclusion Criteria:

1. Patients younger than 18 years old.
2. Pregnant women.
3. Contraindication for the administration of the drug: Hypersensitivity to natural or recombinant interferon beta, and decompensated liver disease.
4. A patient with neuroinvasive disease showing consistent spontaneous improvement over a period of \> 2 days and mRS of below 4.
5. More than 8 days from onset of neurological symptoms in immunocompetent patients and more than 10 days in immunocompromised patients. This time frame will be renewed if a patient with flaccid paralysis develops new onset encephalitis.
6. Patients who are receiving active chemotherapy treatment or suffer concurrent severe viral infection.

Where this trial is running

Tel Aviv

• Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: David Hagin, MD PhD

Conditions West Nile Virus; West Nile Fever Encephalitis; West Nile Fever Myelitis; West Nile Fever With Other Complications; WNV; Encephalitis; Flaccid paralysis; WNV neuroinvasive disease