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Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Primary Purpose

Influenza A Virus Infection

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Interferon-alpha
Oseltamivir
maltose
Sponsored by
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza A Virus Infection focused on measuring interferon-alpha, oseltamivir, drug therapy, combination, influenza, therapies, investigational

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Medical Foundation, LinKou Branch
  • Kaohsiung Veterans General Hospital
  • Show-Chwan Memorial Hospital
  • Taiwan Municipal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interferon-alpha

maltose

Arm Description

Interferon-alpha 150 IU lozenges bid for 5 days

maltose 200 mg maltose lozenges bid for 5 days

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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 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 to resolution of influenza illness
Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.
Symptom improvement
Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.
OTC medication usage
Proportion of use of the OTC medication for fever or influenza symptoms.
Physician visits
Rate of requirement for additional physician visits within 5 days treatment period.
Treatment failure
Rate of treatment failure including hospitalization due to disease progression prior to Day 29.

Full Information

First Posted
June 16, 2010
Last Updated
August 19, 2013
Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
CytoPharm, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01146535
Brief Title
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
Official Title
Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
CytoPharm, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Virus Infection
Keywords
interferon-alpha, oseltamivir, drug therapy, combination, influenza, therapies, investigational

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon-alpha
Arm Type
Experimental
Arm Description
Interferon-alpha 150 IU lozenges bid for 5 days
Arm Title
maltose
Arm Type
Placebo Comparator
Arm Description
maltose 200 mg maltose lozenges bid for 5 days
Intervention Type
Drug
Intervention Name(s)
Interferon-alpha
Other Intervention Name(s)
IFN lozenge
Intervention Description
150 IU lozenges bid for 5 days
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
75 mg capsules bid for 5 days
Intervention Type
Other
Intervention Name(s)
maltose
Other Intervention Name(s)
placebo
Intervention Description
200 mg maltose lozenges bid for 5 days
Primary Outcome Measure Information:
Title
Resolution of fever and flu symptoms
Description
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 Outcome Measure Information:
Title
Clinical response
Description
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
Title
Proportion of poor responders
Description
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
Title
Time to resolution of fever
Description
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
Title
Time to resolution of influenza illness
Description
Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.
Time Frame
Days 1-5
Title
Symptom improvement
Description
Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.
Time Frame
Days 1-5
Title
OTC medication usage
Description
Proportion of use of the OTC medication for fever or influenza symptoms.
Time Frame
Days 1-5
Title
Physician visits
Description
Rate of requirement for additional physician visits within 5 days treatment period.
Time Frame
Days 6-10
Title
Treatment failure
Description
Rate of treatment failure including hospitalization due to disease progression prior to Day 29.
Time Frame
Days 1-28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung Medical Foundation, LinKou Branch
City
Guishan
State/Province
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
State/Province
Zuoying District
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Show-Chwan Memorial Hospital
City
Changhua
ZIP/Postal Code
800
Country
Taiwan
Facility Name
Taiwan Municipal Hospital
City
Tainan
ZIP/Postal Code
701
Country
Taiwan

12. IPD Sharing Statement

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Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

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