Influenza A Virus InfectionPhase 2NCT01146535
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
A Phase 2 study testing Interferon-alpha, Oseltamivir and maltose in people with Influenza A Virus Infection, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 4 sites in Taiwan.
Trial summary
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Influenza A Virus Infection
- What is being tested?
- Interferon-alpha, Oseltamivir and maltose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesTaiwan
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Show-Chwan Memorial Hospital
Changhua, 800
Chang Gung Medical Foundation, LinKou Branch
Guishan, Taoyuan County, 333
Kaohsiung Veterans General Hospital
Kaohsiung City, Zuoying District, 81362
Taiwan Municipal Hospital
Tainan, 701
About this study
Official title: Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
- Conditions
- Influenza A Virus Infection
- Being tested
- Interferon-alpha, Oseltamivir, maltose
- Keywords
- interferon-alpha, oseltamivir, drug therapy, combination, influenza, therapies, investigational
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-alphaDrug
Also called IFN lozenge
150 IU lozenges bid for 5 days
OseltamivirDrug
Also called Tamiflu
75 mg capsules bid for 5 days
maltoseOther
Also called placebo
200 mg maltose lozenges bid for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Interferon-alpha | Experimental | Interferon-alpha
150 IU lozenges bid for 5 days Receives: Drug: Interferon-alpha; Drug: Oseltamivir |
| maltose | Placebo comparator | maltose
200 mg maltose lozenges bid for 5 days Receives: Drug: Oseltamivir; Other: maltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Days 1-5
Secondary outcomes (8)
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).
Measured: Day 3 and Day 6
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).
Measured: Day 3 and Day 6
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).
Measured: Days 1-5
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.
Measured: Days 1-5
Symptom improvement
Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.
Measured: Days 1-5
OTC medication usage
Proportion of use of the OTC medication for fever or influenza symptoms.
Measured: Days 1-5
Physician visits
Rate of requirement for additional physician visits within 5 days treatment period.
Measured: Days 6-10
Treatment failure
Rate of treatment failure including hospitalization due to disease progression prior to Day 29.
Measured: Days 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CytoPharm, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146535
- Sponsor's protocol ID
- QCR09025
- Status last verified
- Aug 2013
- First submitted
- 16 Jun 2010
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection
- ClinicalTrials.gov ID
- NCT01146535
- Acronym / sponsor ID
- QCR09025
- Conditions
- Influenza A Virus Infection
- Keywords
- interferon-alpha, oseltamivir, drug therapy, combination, influenza, therapies, investigational
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- CytoPharm, Inc.
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon-alpha | Experimental | Drug: Interferon-alpha, Drug: OseltamivirInterferon-alpha 150 IU lozenges bid for 5 days |
| maltose | Placebo comparator | Drug: Oseltamivir, Other: maltosemaltose 200 mg maltose lozenges bid for 5 days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-alphaAlso: IFN lozenge150 IU lozenges bid for 5 days | Drug | Interferon-alpha |
| OseltamivirAlso: Tamiflu75 mg capsules bid for 5 days | Drug | Interferon-alpha, maltose |
| maltoseAlso: placebo200 mg maltose lozenges bid for 5 days | Other | maltose |
Primary outcome
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).
8 secondary outcomes
Clinical response
Time frame: Day 3 and Day 6
Proportion of poor responders
Time frame: Day 3 and Day 6
Time to resolution of fever
Time frame: Days 1-5
Time to resolution of influenza illness
Time frame: Days 1-5
Symptom improvement
Time frame: Days 1-5
OTC medication usage
Time frame: Days 1-5
Physician visits
Time frame: Days 6-10
Treatment failure
Time frame: Days 1-28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon-alpha, Oseltamivir and maltose in people with Influenza A Virus Infection, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of fever and flu symptoms (time frame: Days 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.