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 [severe acute respiratory syndrome] or possible SARS
Latest Information Update: 03 Nov 2021
At a glance
- Drugs Interferon alpha-n3 (Primary)
- Indications Coronavirus infections; Severe acute respiratory syndrome
- Focus Pharmacodynamics; Pharmacogenomic
- Sponsors AIM ImmunoTech
- 16 Nov 2005 New trial record.
Most Recent Events
Trial Overview
Purpose
This study is a an open-label, randomized, outpatient study , dose-ranging study of Alferon LDO to evaluate the efficacy and tolerability of interferon alpha-n3 in normal volunteers and/or asymptomatic subjects potentially infected with the SARS-CoV (SARS-associated coronavirus) [severe acute respiratory syndrome] using two dose levels of LDO interferon.
Primary Endpoints
Gene expression analysis [ Time Frame: Days 0, 2, 6, 11, 12, 15, 20 and 40]
Increased expression of genes known to be mediators of interferon response.
Other Endpoints
SARS CoV Antibody
description: Development of clinical SARS-CoV symptomatology
time_frame: Days 0, 15, 20 and 40
SARS-CoV infection
description: Hospitalization for SARS-CoV infection and Death [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Coronavirus infections | treatment | - |
Severe acute respiratory syndrome | treatment | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT00215826 | C-reactive protein (CRP) | Eligibility Criteria |
seryl-tRNA synthetase | Official Title |
Subjects
- Subject Type patients & volunteers
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Number
Planned: 10
Actual: 10
- Sex male & female
- Age Group 18-80 years; adult; elderly
Patient Inclusion Criteria
1. 18-80 years of age. 2. 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). 3. Oral temperature < 100.4°F (<38°C) 4. Subjects must be asymptomatic with regard to SARS related clinical symptoms including any signs of a respiratory illness. 5. Serum creatinine ≤ 1.5 x ULN (upper limit of normal); serum bilirubin ≤ 1.5 x ULN. 6. Total white blood cells (WBC) ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3. 7. Hemoglobin > 10.0 g/dl. 8. ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < 4 times upper normal limit. 9. C-reactive protein serum level in normal range 10. Serum albumin > 2.0 g/dl. 11. Written informed consent. 12. 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.
Patient Exclusion Criteria
1. Pregnant or nursing women, or women not using an effective form of contraception. 2. Less than 18 years of age. 3. Active intravenous (IV) drug users. 4. Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry. 5. Receipt of any immunomodulator such as BCG (bacille Calmette Guerin) vaccine, isoprinosine, or similar experimental agents within 45 days of study entry. 6. 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. 7. Unlikely or unable to comply with the requirements of the protocol. 8. Patients unwilling or unable to give informed consent. 9. Patients on any other concurrent experimental medication. 10. Patients using any form of interferon therapy during the 6 weeks prior to study entry. 11. Hospitalized subjects, or those with an active viral infection other than possible SARS, within 2 weeks of study entry. 12. Transfusion dependent subjects (subjects requiring > 1 unit of packed RBC [red blood cells] per month within the 3 months prior to study entry).
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT00215826 | ClinicalTrials.gov: US National Institutes of Health |
LDO102 | - |
Organisations
- Sponsors AIM ImmunoTech
- Affiliations AIM ImmunoTech; Hemispherx Biopharma
Trial Dates
-
Initiation Dates
Actual : 01 Nov 2004
-
Primary Completion Dates
Actual : 01 Apr 2006
-
End Dates
Actual : 01 Apr 2006
Other Details
- Design open; parallel; prospective; randomised
- Phase of Trial Phase II
- Location Hong Kong
- Focus Pharmacodynamics; Pharmacogenomic
Interventions
Drugs | Route | Formulation |
---|---|---|
Interferon alpha-n3Primary Drug | Oral | Solution |
1
650 IU
Drug: Alferon LDO
2
1300 IU
Drug: Alferon LDO
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Tong TR | Kowloon West Cluster Clinical Research Ethics Committee |
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Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
AIM ImmunoTech |
-
|
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|
Hemispherx Biopharma |
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|
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|
Kowloon West Cluster Clinical Research Ethics Committee |
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|
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|
Princess Margaret Hospital | Lai Chi Kok | Hong-Kong |
Trial History
Event Date | Event Type | Comment |
---|---|---|
23 Jan 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 23 Jan 2020 |
23 Aug 2019 | Other trial event | According to an AIM ImmunoTech media release, the company has changed its name to AIM ImmunoTech, with effective from 3rd Sep 2019. Updated 16 Jan 2020 |
17 Apr 2013 | Biomarker Update | Biomarkers information updated Updated 03 Nov 2021 |
01 Apr 2006 | Status change - completed | Status changed from recruiting to completed as reported by ClinicalTrials.gov. Updated 20 Apr 2013 |
16 Nov 2005 | New trial record | New trial record. Updated 16 Nov 2005 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Hemispherx Biopharma. Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen's(Rm) Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS. Media-Rel 2019;.
Media Release
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