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Completed

NCT Number: NCT01146535

Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

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

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Key information

Conditions

Influenza A Virus Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon-alpha

Drug

150 IU lozenges bid for 5 days

Other names: IFN lozenge

oseltamivir

Drug

75 mg capsules bid for 5 days

Other names: Tamiflu

maltose

Other

200 mg maltose lozenges bid for 5 days

Other names: placebo

Primary outcomes

  1. Resolution of fever and flu symptoms

    Time frame: 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 outcomes

  1. Clinical response

    Time frame: 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).

  2. Proportion of poor responders

    Time frame: 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).

  3. Time to resolution of fever

    Time frame: 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).

  4. Time to resolution of influenza illness

    Time frame: Days 1-5

    Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.

  5. Symptom improvement

    Time frame: Days 1-5

    Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.

  6. OTC medication usage

    Time frame: Days 1-5

    Proportion of use of the OTC medication for fever or influenza symptoms.

  7. Physician visits

    Time frame: Days 6-10

    Rate of requirement for additional physician visits within 5 days treatment period.

  8. Treatment failure

    Time frame: Days 1-28

    Rate of treatment failure including hospitalization due to disease progression prior to Day 29.

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • CytoPharm, Inc.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2010
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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