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
Qualifiers
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
Treatments tested in this trial
- Apomivir®
- Placebo
Treatment groups
196 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov