Influenza A Virus Infection
Conditions
Keywords
interferon-alpha, oseltamivir, drug therapy, combination, influenza, therapies, investigational
Brief summary
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
Interventions
DRUGInterferon-alpha
150 IU lozenges bid for 5 days
DRUGOseltamivir
75 mg capsules bid for 5 days
OTHERmaltose
200 mg maltose lozenges bid for 5 days
Sponsors
CytoPharm, Inc.
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of fever and flu symptoms | Days 1-5 | Time to resolution of influenza symptoms defined as all flu symptoms scored as \<=1 and change in viral load (RT-PCR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of poor responders | Day 3 and Day 6 | 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 to resolution of fever | Days 1-5 | 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 to resolution of influenza illness | Days 1-5 | Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject. |
| Clinical response | Day 3 and Day 6 | 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). |
| OTC medication usage | Days 1-5 | Proportion of use of the OTC medication for fever or influenza symptoms. |
| Physician visits | Days 6-10 | Rate of requirement for additional physician visits within 5 days treatment period. |
| Treatment failure | Days 1-28 | Rate of treatment failure including hospitalization due to disease progression prior to Day 29. |
| Symptom improvement | Days 1-5 | Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject. |
Countries
Taiwan
Outcome results
None listed