Uncomplicated influenza. MedDRA version: 17.1 Level: LLT Classification code 10060078 Term: Influenza serology positive System Organ Class: 100000004848
Conditions
Interventions
Product Name: Favipiravir
Product Code: T-705
Pharmaceutical Form: Tablet
INN or Proposed INN: Favipiravir
CAS Number: 259793-96-9
Current Sponsor code: T-705
Concentration unit: mg milligram(s)
Conce
Sponsors
MDVI, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures. 2. Is an adult male or female between the ages of 18 and 80 years old, inclusive (or according to national standards in each country). 3. Has 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment that began 48 hours or less prior to the first dose of study medication: a. Cough b. Sore throat c. Headache d. Nasal congestion e. Body aches and pains f. Fatigue 4. Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as a. = 38.0°C (= 100.4°F) for subjects =65 years) yes F.1.3.1 Number of subjects for this
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening. 2. Has taken an anti-influenza drug (e.g., amantadine hydrochloride, rimantadine, oseltamivir phosphate, zanamivir hydrate, peramivir or other) within 4 weeks prior to signing the informed consent. 3. Has received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent. 4. Has underlying chronic respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, or active tuberculosis). Subjects with bronchial asthma will be excluded from the study if they presently experience asthma symptoms, are currently requiring treatment, or have had an asthma attack in the past year. 5. At the beginning of the study, is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease). 6. Has a history of gout or is under treatment for gout or hyperuricemia. 7. Has hereditary xanthinuria. 8. Has a history of hypouricemia (under 1 mg/dL) or xanthine calculi of the urinary tract. 9. Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase. 10. Is using adrenocorticosteroids (except topical preparation) or immunosuppressive drugs (e.g., immunosuppressants, anticancer drugs). 11. Has an allergy to acetaminophen (paracetamol) or has a contraindication for acetaminophen (paracetamol). 12. Has a serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days). 13. Has previously received favipiravir (T-705a). 14. Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). 15. Has a history of alcohol or drug abuse in the preceding 2 years. 16. Has a psychiatric disease that is not well controlled (not on a stable regimen for greater than one year). 17. Has taken another investigational drug within 30 days prior to signing the informed consent. 18. Is deemed by the Investigator to be ineligible for any reason. 19. Is employed by or is related to an employee of the clinical study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the clinical efficacy of favipiravir compared with placebo in treating adult subjects who have confirmed influenza.;Secondary Objective: • To further evaluate the clinical and anti-viral effects of favipiravir. • To evaluate the safety of favipiravir in adult subjects with symptoms consistent with uncomplicated influenza. • To characterize the PK of favipiravir when used under clinical conditions. ;Primary end point(s): Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever by temperature (oral) measurements to be < 38.0°C (< 100.4°F) for subjects < 65 years old and < 37.8°C (< 100.0°F) for subjects = 65 years old.;Timepoint(s) of evaluation of this end point: Daily for 21 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue) • Time from the start of study treatment until resolution of fever by temperature (oral) to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (<100.0°F) for subjects = 65 years old • Changes in log-transformed viral load as measured by quantitative polymerase chain reaction (qPCR) and in the determination of median tissue culture infective dose (TCID50), from nasopharyngeal swabs at Visits 2, 3, 4, and 5; and log-transformed viral load (by qPCR and TCID50) area under the curves (AUCs) • The total dose of acetaminophen (paracetamol) used during the study • Incidence of physician-diagnosed secondary respiratory tract infections leading to a prescription for antibiotic therapy • Time to return to normal activity • Safety: Adverse events (AEs) and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis • Population PK analysis of favipiravir with assessment of maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and total daily exposure AUC(0-24h) on Visits 1, 2, 3, 4 and 5 ;Timepoint(s) of evaluation of this end point: Daily for 21 days. | — |
Countries
Australia, Belgium, Bulgaria, Finland, Hungary, Netherlands, New Zealand, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United States
Contacts
Public ContactChief Medical Officer
MDVI, LLC
Outcome results
None listed