Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the
safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and
immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute
respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to
determine an Alferon LDO dose level that increases or upregulates genes known to be mediators
of interferon response. Secondary endpoints include the development of SARS symptomatology,
rate of hospitalization, and mortality rate. In the event that no subjects with recent
exposure to a person with SARS or possible SARS are available, this study will be conducted
with 10 normal volunteers.