Study to Investigate the Efficacy and Safety of Apomivir®

• Status: Unknown status
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Far East Bio-Tec Co., Ltd

Criteria

1. Main inclusion criteria:

1. Females and males aged between 20 and 65

2. 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)

3. Able and willing to comply with the study procedure and give written informed consent

2. Main exclusion criteria:

1. 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

2. Subject with chronic pulmonary diseases or critical condition or already developed severe respiratory distress with hypoxaemia on presentation

3. 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

4. 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

5. 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)

6. Subject who are currently receiving immunosuppressive therapy,

7. 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

8. Known hypersensitivity to any ingredients in Apomivir® or other blue agar

9. Use of any investigational product within 1 month prior to screening