Early Interferon-beta Treatment for West Nile Virus
Early Interferon-beta Treatment for West-Nile Virus Infection
Recruiting
Phase 2Interventional Study
West Nile VirusWest Nile Fever EncephalitisWest Nile Fever MyelitisWest Nile Fever With Other Complications
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
Tel-Aviv Sourasky Medical Center · Government
Who this trial is looking for
This trial is looking for patients with West Nile Virus infection. Participants will receive early treatment with interferon beta to prevent severe disease.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 70 years old.
I have West Nile Virus with neuroinvasive disease.
I am immunocompromised.
I have symptoms like fever and headache.
You may not be able to join if
I am younger than 18 years old.
I am pregnant.
I have liver disease.
I have had improvement from my neuroinvasive disease for over 2 days.
My symptoms started more than 8 days ago.
I am receiving active chemotherapy.
I have a severe viral infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 interfe…
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.
Trial Locations
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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…
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.
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