West Nile Virus

All investigators should submit the protocol and appropriate versions of the Informed Consent and Authorization to Use or Release Individual Health Information for Research forms to their institutional review board for approval, either prior to anticipated use of interferon alpha-n3 or as an emergency approval on a case-by-case basis. Interferon alpha-n3 will be supplied free of charge as Alferon for use in this protocol. Each responsible local investigator will receive $1,000 per fully complete case report form.

Please contact Dr. James J. Rahal or Dr. Wehbeh Wehbeh prior to patient enrollment. Enrollment must occur within five days of hospitalization and does not require prior serologic confirmation of West Nile infection.

Documentation

Double-Blinded, Placebo Controlled Trial of Alpha-Interferon (Alferon) Therapy for West Nile Meningoencephalitis (Protocol WN-102) (PDF) (Revised 7/26/04)

Sample Informed Consent (PDF)

Sample Authorization to Use or Release Individual Health Information for Research (PDF)

Appendix 1: NIH Stroke Scale (PDF)

Appendix 2: Barthel Index (PDF)

Appendix 3: Common Toxicity Criteria ver. 2.0 (PDF)

Appendix 4: Adverse Event Form (PDF)

Appendix 5: Time and Event Schedule (PDF)

Appendix 6: Protocol For Administration of Study Mediication (PDF) (Revised 7/28/04)

Supporting Documents:
Effects of Interferon -alpha2b Therapy on SLV (PDF)
44th Annual ICAAC Abstract (PDF)