Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Influenza A Virus Infection

Interventions

Interferon-alphaDRUG

150 IU lozenges bid for 5 days

OseltamivirDRUG

75 mg capsules bid for 5 days

maltoseOTHER

200 mg maltose lozenges bid for 5 days

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Chang Gung Medical Foundation, LinKou Branch

Guishan, Taoyuan County, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Zuoying District, Taiwan

Show-Chwan Memorial Hospital

Changhua, Taiwan

Taiwan Municipal Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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