Influenza Clinical Trial
Official title:
A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms
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.
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
1. = >= 37.2 to < 38.0°C
2. = >= 38.0 to < 39.0°C
3. = >= 39.0 °C
Other influenza symptoms (such as cough, nasal obstruction, sore throat, fatigue, headache
and myalgias) will also be assessed using a 4-point scale:
0 = none,
1. = mild,
2. = moderate,
3. = severe
The level of interference on daily activities (including running, lifting heavy objects,
participating in strenuous sports, moderate activities), such as moving a table, pushing a
vacuum cleaner, bowling, or playing golf, lifting or carrying groceries, climbing several
flights of stairs, climbing one flight of stairs, bending, kneeling, or stooping, walking
more than a mile, walking several blocks, walking one blocks, and bathing or dressing
yourself, will be assessed according to a 3-point scale
0 = no, no limited
1. = yes, limited a little
2. = yes, limited a lot
Confirmatory tests for infective virus strain, real-time RT-PCR and viral culture will be
conducted at baseline. In the following study visits, real-time RT-PCR will be performed to
measure the influenza viral load/titer in nasopharyngeal/throat swabs specimen. For those who
have been completely cured prior to Day 15, the real-time RT-PCR assessment could be omitted
on Day 29. All subjects enrolled will be followed until the end of study, but only subjects
with influenza PCR or viral culture positive could be evaluable population.
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