Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Study Overview
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Brief Summary
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This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.

Official Title
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Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection

Conditions
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Influenza A Virus Infection

Intervention / Treatment
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* Drug: Interferon-alpha
* Drug: Oseltamivir
* Other: maltose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fever >=38C one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of < 48 hours' duration body weight > 40 kg positive for influenza A (nasal swab rapid test) Exclusion Criteria: pregnancy/lactation history of depression or psychiatric disorders history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders use of immunosuppressive therapy HIV infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon-alpha<br>Interferon-alpha 150 IU lozenges bid for 5 days | Drug: Interferon-alpha<br>* 150 IU lozenges bid for 5 days<br>* Other names: IFN lozenge;Drug: Oseltamivir<br>* 75 mg capsules bid for 5 days<br>* Other names: Tamiflu;|
| Placebo Comparator: maltose<br>maltose 200 mg maltose lozenges bid for 5 days | Drug: Oseltamivir<br>* 75 mg capsules bid for 5 days<br>* Other names: Tamiflu;Other: maltose<br>* 200 mg maltose lozenges bid for 5 days<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Days 1-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | Days 1-5 | 
| Symptom improvement | Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject. | Days 1-5 | 
| OTC medication usage | Proportion of use of the OTC medication for fever or influenza symptoms. | Days 1-5 | 
| Physician visits | Rate of requirement for additional physician visits within 5 days treatment period. | Days 6-10 | 
| Treatment failure | Rate of treatment failure including hospitalization due to disease progression prior to Day 29. | Days 1-28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interferon-alpha, oseltamivir, drug therapy, combination, influenza, therapies, investigational