Study to Investigate the Efficacy and Safety of Apomivir®

NCT01677689 | Not Yet Recruiting Phase 2

• 1 other identifier: QCR09032
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

oral temperature; respiratory symptom; cough; nasal obstruction; sore throat; fever

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).

  Safety endpoints: 1. Change in laboratory data 2. Adverse events 3. Serious adverse events (SAE)

  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 Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.

  from day 1 to day 29, depends on the time to sympton resolution of individual subjects.

Secondary Outcomes (6)

• Change in virus titer.

  Day 3, 6 compared to baseline (Day 1)

• Time to achieve afebrile

  after initiation of study treatment

• Severity of influenza symptom score during study period

  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

  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

  twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured

Study Arms (2)

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

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.

Drug: Apomivir®

Interventions

Apomivir® DRUG

Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.

Also known as: FE-L-APO(drug substance)

Study Group

Placebo DRUG

Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.

Control Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far East Bio-Tec Co., Ltd: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 7521897 BACKGROUND

• Shih 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.

  PMID: 19299804 BACKGROUND

• Gonzalez 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.

  PMID: 10366332 BACKGROUND

• Shih 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.

  PMID: 12629652 BACKGROUND

• Reagan-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.

  PMID: 17942826 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Influenza, Human; Signs and Symptoms, Respiratory; Cough; Nasal Obstruction; Pharyngitis; Fever

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Body Temperature Changes

Study Officials

• Liang-Wen Hang, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• YI-HSIANG CHEN

  Far East Bio-Tec Co., Ltd

  STUDY DIRECTOR

Central Study Contacts

YI-HSIANG CHEN

CONTACT

+886-2-2655-8198; mrx1025@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

TW (1)