Study to Investigate the Efficacy and Safety of Apomivir®
ConditionInfluenza
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-65
SponsorFar East Bio-Tec Co., Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Females and males aged between 20 and 65
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
Disqualifiers
Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception
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
Trial design
Design model
Parallel
Treatments tested in this trial
Apomivir®
DrugStudy Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
Placebo
DrugControl Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: Control GroupPlacebo comparator 1 intervention
Group B: Study GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
from day1 to day 29, the entire treatment period and follow-up period.2
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.
Time frame
from day 1 to day 29, depends on the time to sympton resolution of individual subjects.Secondary outcomes
1
Change in virus titer.
To evaluate the change in virus titer assessed by real-time RT-PCR15.
Time frame
Day 3, 6 compared to baseline (Day 1)2
Time to achieve afebrile
Time to bring down a fever (oral temperature \< 37.2˚C)
Time frame
after initiation of study treatment3
Severity of influenza symptom score during study period
All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
Time frame
twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured4
Level of interference on daily activity and time to alleviation of the interference during study period
All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
Time frame
twice daily from Day 1 to Day 6 and once daily until Day 29 or completely curedSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: