Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers

Severe Acute Respiratory Syndrome Clinical Trial

Official title: A Randomized, Dose-ranging Study of Alferon® LDO {Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)} in Normal Volunteers and/or Asymptomatic Subjects With Exposure to a Person Known to Have SARS or Possible SARS

Status Completed

Clinical Trial 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.

Clinical Trial Description

This study will be an open-label, randomized, outpatient study in subjects potentially infected with the SARS-CoV (SARS-associated coronavirus) or normal volunteers using two dose levels of LDO interferon.

Subjects will be randomized to receive Alferon® LDO (natural interferon alfa-n3) in a buffer solution once each day for 10 consecutive days at doses equal to 650 IU or 1300 IU/day.

Pretherapy baseline evaluations will be performed prior to randomization.

Subjects will be randomly assigned to each dose level, and both dosage levels will be started concurrently. Drug will be dispensed for a ten day treatment period, during which time any clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1, 5, and 10 on study days 2, 6, and 11, respectively.

The conduct of this study will comply with International Conference on Harmonisation - Good Clinical Practice (ICH - GCP) and the 1996 or later version of the Declaration of Helsinki. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome

• NCT number: NCT00215826
• Study type: Interventional
• Source: Hemispherx Biopharma
• Status: Completed
• Phase: Phase 2
• Start date: November 2004
• Completion date: April 2006