InfluenzaPhase 2NCT01677689
Study to Investigate the Efficacy and Safety of Apomivir®
A Phase 2 study testing Apomivir® in people with Influenza, run by Far East Bio-Tec Co., Ltd at 1 site in Taiwan.
Trial summary
Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Apomivir®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 May 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Main inclusion criteria:
- Females and males aged between 20 and 65
- Presumptive diagnosis of influenza based on the following clinical characteristics:
- Present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
- Positive for influenza A or B (nasopharyngeal/throat swab - rapid test)
- Able and willing to comply with the study procedure and give written informed consent
- Main exclusion criteria:
- Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception
- Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal
- Subject with chronic pulmonary diseases or critical condition or already developed severe respiratory distress with hypoxaemia on presentation
- Subject with a history of non-febrile convulsions, neuromuscular disorders or cognitive dysfunction that may compromise respiratory secretions, or who are currently receiving anticonvulsive agents
- Subject with clinically important illness, malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study
- Subject with significant abnormal laboratory findings (hemoglobin level < 9.0 g/dL, WBC < 4000/mm3, platelet count < 100,000/mm3, ALT or AST > 2.5 x upper limit of normal (ULN), or estimated creatinine clearance < 30 mL/min within 4 weeks prior to baseline)
- Subject who are currently receiving immunosuppressive therapy,
- Subject has taken daily supplement(s) containing blue agar within 1 month prior to screening, or any other medication that may affect the study results
- Known hypersensitivity to any ingredients in Apomivir® or other blue agar
- Use of any investigational product within 1 month prior to screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
China Medical University Hospital
Taichung, 40447
Der-Yang Cho, M.D., +886-4-22052121, answer@mail.cmuh.org.tw
Liang-Wen Hang, M.D.
About this study
Official title: A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms
Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause illness, paralysis and even death, especially in children and elderly people. This phase II study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in subjects with seasonal influenza.
Read the detailed description
This is a prospective, randomized, double-blind, parallel, placebo-controlled, multi-center study. Approximately 196 subjects with fever defined as body temperature >= 38˚C, with at least one respiratory symptom and one other constitutional symptom will be invited into this study to target 156 evaluable subjects. A nasopharyngeal/throat swabs rapid test for influenza A and B will be conducted and only subjects with positive results could be recruited. All eligible subjects will be randomized to one of the following treatment group in a 1:1 ratio.
Study Group: Apomivir® 1 capsule (120 mg/cap) twice daily for 5 days Control Group: Placebo 1 capsule twice daily for 5 days A pack of acetaminophen (500 mg) will be provided at enrollment. All flu symptom relief agents could be used only for rescue use of persistent fever or flu symptoms (>= 24 hours). A digital thermometer and diary card will be dispensed at baseline (Day 1). Subjects will be instructed to complete the body temperature record, and daily record regarding the severity of their influenza symptoms and the level of interference on daily activity. The monitoring frequency will be twice daily (after drug administration) from Day 1 to Day 5, and cut down to once daily until Day 29 or completed cure (defined as remission of all flu symptoms and interferences). Treatment failure is defined as secondary illnesses, antibiotic use and hospitalization due to disease progression.
For safety and efficacy assessments, all subjects should return on Day 3, 6 and 15. For subjects who are not completely cured before Day 15 (Visit 4), further therapy will be conducted and they should return on Day 29; for those who are completely cured, only a telephone follow-up will be conducted on Day 29.
The severity of fever will be scored using a 4-point scale:
0 = < 37.2°C
- = >= 37.2 to < 38.0°C
- = >= 38.0 to < 39.0°C
- = >= 39.0 °C
Other influenza symptoms (such as cough, nasal obstruction, sore throat, fatigue, headache and myalgias) will also be assessed using a 4-point scale:
0 = none,
- = mild,
- = moderate,
- = severe
The level of interference on daily activities (including running, lifting heavy objects, participating in strenuous sports, moderate activities), such as moving a table, pushing a vacuum cleaner, bowling, or playing golf, lifting or carrying groceries, climbing several flights of stairs, climbing one flight of stairs, bending, kneeling, or stooping, walking more than a mile, walking several blocks, walking one blocks, and bathing or dressing yourself, will be assessed according to a 3-point scale
0 = no, no limited
- = yes, limited a little
- = yes, limited a lot
Confirmatory tests for infective virus strain, real-time RT-PCR and viral culture will be conducted at baseline. In the following study visits, real-time RT-PCR will be performed to measure the influenza viral load/titer in nasopharyngeal/throat swabs specimen. For those who have been completely cured prior to Day 15, the real-time RT-PCR assessment could be omitted on Day 29. All subjects enrolled will be followed until the end of study, but only subjects with influenza PCR or viral culture positive could be evaluable population.
- Conditions
- Influenza
- Being tested
- Apomivir®, Placebo
- Keywords
- oral temperature, respiratory symptom, cough, nasal obstruction, sore throat, fever
- Medical subject headings
- Influenza, Human, Signs and Symptoms, Respiratory, Cough, Nasal Obstruction, Pharyngitis, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apomivir®Drug
Also called FE-L-APO(drug substance)
Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
PlaceboDrug
Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal Receives: Drug: Placebo |
| Study Group | Experimental | Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal. Receives: Drug: Apomivir® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
Safety endpoints:
- Change in laboratory data
- Adverse events
- Serious adverse events (SAE)
Measured: from day1 to day 29, the entire treatment period and follow-up period.
To evaluate the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.
The time to resolution of influenza symptom is defined as the duration from the study drug initiation to all flu symptom scores ≤ 1. Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.
Measured: from day 1 to day 29, depends on the time to sympton resolution of individual subjects.
Secondary outcomes (6)
Change in virus titer.
To evaluate the change in virus titer assessed by real-time RT-PCR15.
Measured: Day 3, 6 compared to baseline (Day 1)
Time to achieve afebrile
Time to bring down a fever (oral temperature < 37.2˚C)
Measured: after initiation of study treatment
Severity of influenza symptom score during study period
All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
Measured: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
Level of interference on daily activity and time to alleviation of the interference during study period
All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
Measured: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
Proportion of rescue medication used for fever or influenza symptoms during study period
All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
Measured: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
Proportion and time to treatment failure during study period
Proportion and time to treatment failure (including secondary illnesses, antibiotic use and hospitalization due to disease progression) during study period
Measured: from day 1 to day 29, including treatment period and follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start31 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far East Bio-Tec Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liang-Wen Hang, MD, Principal investigator, China Medical University HospitalYI-HSIANG CHEN, Study director, Far East Bio-Tec Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677689
- Sponsor's protocol ID
- QCR09032
- Status last verified
- May 2025
- First submitted
- 30 Aug 2012
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lynch G, Low L, Li S, Sloane A, Adams S, Parish C, Kemp B, Cunningham AL. Sulfated polyanions prevent HIV infection of lymphocytes by disruption of the CD4-gp120 interaction, but do not inhibit monocyte infection. J Leukoc Biol. 1994 Sep;56(3):266-72. doi: 10.1002/jlb.56.3.266.
PubMed 7521897Shih CM, Cheng SN, Wong CS, Kuo YL, Chou TC. Antiinflammatory and antihyperalgesic activity of C-phycocyanin. Anesth Analg. 2009 Apr;108(4):1303-10. doi: 10.1213/ane.0b013e318193e919.
PubMed 19299804Gonzalez R, Rodriguez S, Romay C, Ancheta O, Gonzalez A, Armesto J, Remirez D, Merino N. Anti-inflammatory activity of phycocyanin extract in acetic acid-induced colitis in rats. Pharmacol Res. 1999 Jan;39(1):55-9.
PubMed 10366332Shih SR, Tsai KN, Li YS, Chueh CC, Chan EC. Inhibition of enterovirus 71-induced apoptosis by allophycocyanin isolated from a blue-green alga Spirulina platensis. J Med Virol. 2003 May;70(1):119-25. doi: 10.1002/jmv.10363.
PubMed 12629652Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008 Mar;22(3):659-61. doi: 10.1096/fj.07-9574LSF. Epub 2007 Oct 17.
PubMed 17942826
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms
- ClinicalTrials.gov ID
- NCT01677689
- Acronym / sponsor ID
- QCR09032
- Conditions
- Influenza
- Keywords
- oral temperature, respiratory symptom, cough, nasal obstruction, sore throat, fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Far East Bio-Tec Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Sep 2012 (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.
Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause illness, paralysis and even death, especially in children and elderly people. This phase II study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in subjects with seasonal influenza.
Detailed description
This is a prospective, randomized, double-blind, parallel, placebo-controlled, multi-center study. Approximately 196 subjects with fever defined as body temperature >= 38˚C, with at least one respiratory symptom and one other constitutional symptom will be invited into this study to target 156 evaluable subjects. A nasopharyngeal/throat swabs rapid test for influenza A and B will be conducted and only subjects with positive results could be recruited. All eligible subjects will be randomized to one of the following treatment group in a 1:1 ratio.
Study Group: Apomivir® 1 capsule (120 mg/cap) twice daily for 5 days Control Group: Placebo 1 capsule twice daily for 5 days A pack of acetaminophen (500 mg) will be provided at enrollment. All flu symptom relief agents could be used only for rescue use of persistent fever or flu symptoms (>= 24 hours). A digital thermometer and diary card will be dispensed at baseline (Day 1). Subjects will be instructed to complete the body temperature record, and daily record regarding the severity of their influenza symptoms and the level of interference on daily activity. The monitoring frequency will be twice daily (after drug administration) from Day 1 to Day 5, and cut down to once daily until Day 29 or completed cure (defined as remission of all flu symptoms and interferences). Treatment failure is defined as secondary illnesses, antibiotic use and hospitalization due to disease progression.
For safety and efficacy assessments, all subjects should return on Day 3, 6 and 15. For subjects who are not completely cured before Day 15 (Visit 4), further therapy will be conducted and they should return on Day 29; for those who are completely cured, only a telephone follow-up will be conducted on Day 29.
The severity of fever will be scored using a 4-point scale:
0 = < 37.2°C
- = >= 37.2 to < 38.0°C
- = >= 38.0 to < 39.0°C
- = >= 39.0 °C
Other influenza symptoms (such as cough, nasal obstruction, sore throat, fatigue, headache and myalgias) will also be assessed using a 4-point scale:
0 = none,
- = mild,
- = moderate,
- = severe
The level of interference on daily activities (including running, lifting heavy objects, participating in strenuous sports, moderate activities), such as moving a table, pushing a vacuum cleaner, bowling, or playing golf, lifting or carrying groceries, climbing several flights of stairs, climbing one flight of stairs, bending, kneeling, or stooping, walking more than a mile, walking several blocks, walking one blocks, and bathing or dressing yourself, will be assessed according to a 3-point scale
0 = no, no limited
- = yes, limited a little
- = yes, limited a lot
Confirmatory tests for infective virus strain, real-time RT-PCR and viral culture will be conducted at baseline. In the following study visits, real-time RT-PCR will be performed to measure the influenza viral load/titer in nasopharyngeal/throat swabs specimen. For those who have been completely cured prior to Day 15, the real-time RT-PCR assessment could be omitted on Day 29. All subjects enrolled will be followed until the end of study, but only subjects with influenza PCR or viral culture positive could be evaluable population.
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 |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPlacebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal |
| Study Group | Experimental | Drug: Apomivir®Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Apomivir®Also: FE-L-APO(drug substance)Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal. | Drug | Study Group |
| PlaceboControl Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal. | Drug | Control Group |
Primary outcome
To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
Time frame: from day1 to day 29, the entire treatment period and follow-up period.
Safety endpoints: 1. Change in laboratory data 2. Adverse events 3. Serious adverse events (SAE)
To evaluate the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.
Time frame: from day 1 to day 29, depends on the time to sympton resolution of individual subjects.
The time to resolution of influenza symptom is defined as the duration from the study drug initiation to all flu symptom scores ≤ 1. Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.
6 secondary outcomes
Change in virus titer.
Time frame: Day 3, 6 compared to baseline (Day 1)
Time to achieve afebrile
Time frame: after initiation of study treatment
Severity of influenza symptom score during study period
Time frame: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
Level of interference on daily activity and time to alleviation of the interference during study period
Time frame: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
Proportion of rescue medication used for fever or influenza symptoms during study period
Time frame: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
Proportion and time to treatment failure during study period
Time frame: from day 1 to day 29, including treatment period and follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 7521897Lynch G, Low L, Li S, Sloane A, Adams S, Parish C, Kemp B, Cunningham AL. Sulfated polyanions prevent HIV infection of lymphocytes by disruption of the CD4-gp120 interaction, but do not inhibit monocyte infection. J Leukoc Biol. 1994 Sep;56(3):266-72. doi: 10.1002/jlb.56.3.266.
- Background: PubMed 19299804Shih CM, Cheng SN, Wong CS, Kuo YL, Chou TC. Antiinflammatory and antihyperalgesic activity of C-phycocyanin. Anesth Analg. 2009 Apr;108(4):1303-10. doi: 10.1213/ane.0b013e318193e919.
- Background: PubMed 10366332Gonzalez R, Rodriguez S, Romay C, Ancheta O, Gonzalez A, Armesto J, Remirez D, Merino N. Anti-inflammatory activity of phycocyanin extract in acetic acid-induced colitis in rats. Pharmacol Res. 1999 Jan;39(1):55-9.
- Background: PubMed 12629652Shih SR, Tsai KN, Li YS, Chueh CC, Chan EC. Inhibition of enterovirus 71-induced apoptosis by allophycocyanin isolated from a blue-green alga Spirulina platensis. J Med Virol. 2003 May;70(1):119-25. doi: 10.1002/jmv.10363.
- Background: PubMed 17942826Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008 Mar;22(3):659-61. doi: 10.1096/fj.07-9574LSF. Epub 2007 Oct 17.
- The drug substance of the IP is the same with a marked nutrition supplement. And this is the official product page of the marked nutrition supplement.Link provided by the sponsor.
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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.
Liang-Wen Hang, MD principal investigator
China Medical University Hospital
YI-HSIANG CHEN study director
Far East Bio-Tec Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apomivir® in people with Influenza, run by Far East Bio-Tec Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YI-HSIANG CHEN (+886-2-2655-8198, mrx1025@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.). (time frame: from day1 to day 29, the entire treatment period and follow-up period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01677689, which also lists 5 linked publications.
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 14 May 2025.