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 range20 Years – 65 Years
SexALL
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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
✕. 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
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.