Study to Investigate the Efficacy and Safety of Apomivir® (NCT01677689) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Investigate the Efficacy and Safety of Apomivir®
Taiwan196 participantsStarted 2026-05-31
Plain-language 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 (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.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Females and males aged between 20 and 65
. Presumptive diagnosis of influenza based on the following clinical characteristics:
. Able and willing to comply with the study procedure and give written informed consent
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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
Timeframe: from day1 to day 29, the entire treatment period and follow-up period.
2
To evaluate the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.
Timeframe: from day 1 to day 29, depends on the time to sympton resolution of individual subjects.
. 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