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Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Information source: Amarillo Biosciences, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza A Virus Infection

Intervention: Interferon-alpha (Drug); Oseltamivir (Drug); maltose (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Amarillo Biosciences, Inc.

Summary

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

Clinical Details

Official title: Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Resolution of fever and flu symptoms

Secondary outcome:

Clinical response

Proportion of poor responders

Time to resolution of fever

Time to resolution of influenza illness

Symptom improvement

OTC medication usage

Physician visits

Treatment failure

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Show-Chwan Memorial Hospital, Changhua 800, Taiwan

Taiwan Municipal Hospital, Tainan 701, Taiwan

Chang Gung Medical Foundation, LinKou Branch, Guishan, Taoyuan County 333, Taiwan

Kaohsiung Veterans General Hospital, Kaohsiung City, Zuoying District 81362, Taiwan

Additional Information

Starting date: January 2011
Last updated: August 19, 2013

Page last updated: August 23, 2015

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