Study to Investigate the Efficacy and Safety of Apomivir®
Condition(s) studied
Investigational drug(s) / intervention(s)
Apomivir®: Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
Placebo: 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 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.
Eligibility
Primary outcome measure(s)
- To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.). — 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. — 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 Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01677689 on ClinicalTrials.gov ↗ ← All trials in China