Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

NCT ID: NCT01146535

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Influenza A Virus Infection

Keywords

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interferon-alpha oseltamivir drug therapy, combination influenza therapies, investigational

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Interferon-alpha

Interferon-alpha

150 IU lozenges bid for 5 days

Group Type EXPERIMENTAL

Interferon-alpha

Intervention Type DRUG

150 IU lozenges bid for 5 days

Oseltamivir

Intervention Type DRUG

75 mg capsules bid for 5 days

maltose

maltose

200 mg maltose lozenges bid for 5 days

Group Type PLACEBO_COMPARATOR

Oseltamivir

Intervention Type DRUG

75 mg capsules bid for 5 days

maltose

Intervention Type OTHER

200 mg maltose lozenges bid for 5 days

Interventions

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Interferon-alpha

150 IU lozenges bid for 5 days

Intervention Type DRUG

Oseltamivir

75 mg capsules bid for 5 days

Intervention Type DRUG

maltose

200 mg maltose lozenges bid for 5 days

Intervention Type OTHER

Other Intervention Names

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IFN lozenge Tamiflu placebo

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytoPharm, Inc.

INDUSTRY

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Medical Foundation, LinKou Branch

Guishan, Taoyuan County, Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, Zuoying District, Taiwan

Site Status

Show-Chwan Memorial Hospital

Changhua, , Taiwan

Site Status

Taiwan Municipal Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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QCR09025

Identifier Type: -

Identifier Source: org_study_id