A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
Study Overview
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.
Detailed Description
This is a prospective, randomized, double-blind, parallel, placebo-controlled, multi-center study. Approximately 196 subjects with fever defined as body temperature >= 38˚C, with at least one respiratory symptom and one other constitutional symptom will be invited into this study to target 156 evaluable subjects. A nasopharyngeal/throat swabs rapid test for influenza A and B will be conducted and only subjects with positive results could be recruited. All eligible subjects will be randomized to one of the following treatment group in a 1:1 ratio.
Study Group: Apomivir® 1 capsule (120 mg/cap) twice daily for 5 days Control Group: Placebo 1 capsule twice daily for 5 days A pack of acetaminophen (500 mg) will be provided at enrollment. All flu symptom relief agents could be used only for rescue use of persistent fever or flu symptoms (>= 24 hours). A digital thermometer and diary card will be dispensed at baseline (Day 1). Subjects will be instructed to complete the body temperature record, and daily record regarding the severity of their influenza symptoms and the level of interference on daily activity. The monitoring frequency will be twice daily (after drug administration) from Day 1 to Day 5, and cut down to once daily until Day 29 or completed cure (defined as remission of all flu symptoms and interferences). Treatment failure is defined as secondary illnesses, antibiotic use and hospitalization due to disease progression.
For safety and efficacy assessments, all subjects should return on Day 3, 6 and 15. For subjects who are not completely cured before Day 15 (Visit 4), further therapy will be conducted and they should return on Day 29; for those who are completely cured, only a telephone follow-up will be conducted on Day 29.
The severity of fever will be scored using a 4-point scale:
0 = < 37.2°C
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Control Group
Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal
Intervention: Placebo (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.
Intervention: Apomivir® (Drug)
Outcomes
Primary Outcomes
To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
- 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)
- Proportion and time to treatment failure during study period(from day 1 to day 29, including treatment period and follow-up period)
- 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)
- Change in virus titer.(Day 3, 6 compared to baseline (Day 1))
- Time to achieve afebrile(after initiation of study treatment)