Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Phase 2

Completed

• Conditions: Influenza A Virus Infection
• Interventions: Drug: Interferon-alpha; Drug: Oseltamivir; Other: maltose

• Registration Number: NCT01146535
• Lead Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferon-alpha	Oseltamivir	Interferon-alpha 150 IU lozenges bid for 5 days
maltose	maltose	maltose 200 mg maltose lozenges bid for 5 days
Interferon-alpha	Interferon-alpha	Interferon-alpha 150 IU lozenges bid for 5 days
maltose	Oseltamivir	maltose 200 mg maltose lozenges bid for 5 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
Symptom improvement	Days 1-5	Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.
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.

Trial Locations

Locations (4)

Chang Gung Medical Foundation, LinKou Branch; 🇨🇳 Guishan, Taoyuan County, Taiwan

Show-Chwan Memorial Hospital; 🇨🇳 Changhua, Taiwan

Taiwan Municipal Hospital; 🇨🇳 Tainan, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Zuoying District, Taiwan