Early Interferon-beta Treatment for West Nile Virus Infection to Prevent Severe Neuroinvasive Disease

What this Trial Is About

West Nile virus (WNV) is a mosquito-borne virus that usually causes a mild illness but can lead to severe brain infection called neuroinvasive disease in a small number of cases. This severe form can be life-threatening, especially in older adults. Researchers believe that certain antibodies against interferons may explain why some patients develop serious disease, and they are studying whether early treatment with interferon beta can help prevent severe neuroinvasive WNV disease. This is a phase 2, randomized, double-blinded placebo-controlled trial evaluating subcutaneous injections of interferon beta-1a (Rebif) at 44 mcg every 48 hours for a total of three doses. Participants will be randomly assigned to receive either interferon beta-1a or a placebo (normal saline) under this schedule. Patients diagnosed with WNV infection will be recruited and treated either in the hospital or outpatient clinic, with follow-up visits every three months for one year. Participants will undergo diagnostic tests including blood, urine, and cerebrospinal fluid samples to confirm WNV infection and to study antibodies and inflammatory markers. They will be monitored for clinical outcomes such as death, intubation, neurological function, and cognitive assessments at various time points up to 12 months. Safety monitoring will include routine blood work. Data will be securely stored, and researchers will review clinical progress and mortality over the year-long follow-up period.

Early Interferon-beta Treatment for West-Nile Virus Infection