Status:
COMPLETED
Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers
Lead Sponsor:
AIM ImmunoTech Inc.
Conditions:
Severe Acute Respiratory Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 as...
Detailed 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 interf...
Eligibility Criteria
Inclusion
- 18-80 years of age.
- Asymptomatic with close contact within the last 5 days with a person known to have possible SARS (SARS RUI-2 (SARS Report under investigation), RUI-3, RUI-4) or probable SARS or confirmed SARS using the Centers for Disease Control and Prevention (CDC) Supplement B: SARS Surveillance, Appendix B1: Revised Council of State and Territorial Epidemiologists (CSTE) SARS Surveillance Case Definition (Attachment II).
- Oral temperature \< 100.4°F (\<38°C)
- Subjects must be asymptomatic with regard to SARS related clinical symptoms including any signs of a respiratory illness.
- Serum creatinine ≤ 1.5 x ULN (upper limit of normal); serum bilirubin ≤ 1.5 x ULN.
- Total white blood cells (WBC) ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3.
- Hemoglobin \> 10.0 g/dl.
- ALT (alanine aminotransferase) and AST (aspartate aminotransferase) \< 4 times upper normal limit.
- C-reactive protein serum level in normal range
- Serum albumin \> 2.0 g/dl.
- Written informed consent.
- Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test prior to randomization.
Exclusion
- Pregnant or nursing women, or women not using an effective form of contraception.
- Less than 18 years of age.
- Active intravenous (IV) drug users.
- Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.
- Receipt of any immunomodulator such as BCG (bacille Calmette Guerin) vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.
- Evidence of HIV or other viral infections including chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period.
- Unlikely or unable to comply with the requirements of the protocol.
- Patients unwilling or unable to give informed consent.
- Patients on any other concurrent experimental medication.
- Patients using any form of interferon therapy during the 6 weeks prior to study entry.
- Hospitalized subjects, or those with an active viral infection other than possible SARS, within 2 weeks of study entry.
- Transfusion dependent subjects (subjects requiring \> 1 unit of packed RBC \[red blood cells\] per month within the 3 months prior to study entry).
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00215826
Start Date
November 1 2004
End Date
April 1 2006
Last Update
April 17 2013
Active Locations (1)
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1
Princess Margaret Hospital
Lai Chi Kok, Kowloon, Hong Kong