A Phase 2 interventional study of Interferon-alpha and Oseltamivir in Influenza A Virus Infection, sponsored by Ainos, Inc. (f/k/a Amarillo Biosciences Inc.. Completed at 4 sites in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-21.
Sponsored by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. · Phase 2, Interventional, and Treatment
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Ainos, Inc. (f/k/a Amarillo Biosciences Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Interferon-alpha 150 IU lozenges bid for 5 days
Drug: Interferon-alpha · Drug: Oseltamivir
maltose 200 mg maltose lozenges bid for 5 days
Drug: Oseltamivir · Other: maltose
150 IU lozenges bid for 5 days
Also known as: IFN lozenge
75 mg capsules bid for 5 days
Also known as: Tamiflu
200 mg maltose lozenges bid for 5 days
Also known as: placebo
Resolution of fever and flu symptoms
Time to resolution of influenza symptoms defined as all flu symptoms scored as \<=1 and change in viral load (RT-PCR).
Time frame: Days 1-5
Clinical response
Proportion of clinical responders on Day 3 and Day 6: defined as no fever (oral temperature \< 38 °C and no subjective fever) AND resolution of influenza illness (all flu symptoms and interference scored as ≤ 1).
Time frame: Day 3 and Day 6
Proportion of poor responders
Proportion of poor responders on both Day 3 and Day 6: defined as subjects with fever (oral temperature ≥ 38 °C or any record of subjective fever) OR unresolved influenza illness (1 or more flu symptoms/interferences scored as \> 1).
Time frame: Day 3 and Day 6
Time to resolution of fever
Time to bring down a fever (oral temperature \< 38 °C and no subjective fever) and time to return to afebrile state (oral temperature ≤ 37.2 °C and no subjective fever).
Time frame: Days 1-5
Time to resolution of influenza illness
Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.
Time frame: Days 1-5
Symptom improvement
Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.
Time frame: Days 1-5
OTC medication usage
Proportion of use of the OTC medication for fever or influenza symptoms.
Time frame: Days 1-5
Physician visits
Rate of requirement for additional physician visits within 5 days treatment period.
Time frame: Days 6-10
Treatment failure
Rate of treatment failure including hospitalization due to disease progression prior to Day 29.
Time frame: Days 1-28
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Ainos, Inc. (f/k/a Amarillo Biosciences Inc.