None listed
Conditions
Interventions
Tablets. Oral. The treatment period is 5 days. Favipiravir BID: Day 1: 1800 mg (1st loading dose) + 1800 mg (2nd loading dose). Days 2-5: 800 mg BID. Placebo BID: matching pill numbers and presentatio
Sponsors
MDVI, LLC,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Understands the requirements of the study and provides written informed consent prior to start any study-related procedures. • Male or female, between the ages: 18 - 80, inclusive. • Has 2 or more of the symptoms: Cough, Sore throat, Headache, Nasal congestion, Body aches and pains, Fatigue. • Has a fever at the 1st visit or in the 6 hours prior if antipyretics were taken: ≥ 38.0°C for subjects < 65 years old; or ≥ 37.8°C for subjects ≥ 65 years old. • Tests positive for influenza A or B. Confirmed by Rapid Antigen Test (RAT) or real time polymerase chain reaction (PCR) or diagnostic assay (e.g. non-study RAT or PCR) from another clinic. A subject testing negative by RAT may still be enrolled if the Medical Monitor and Investigator agree that there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have influenza by RAT or another laboratory test. • Male must: Be sterile or Agree he will not donate sperm during the study or will strictly adhere to the contraceptive measures mentioned in the protocol. • Female must: Be unable to bear children OR have a male partner incapable of fathering a child OR have a negative pregnancy test at screening and not have had unprotected sex within the last month or used a method of contraception within the last month AND • If she is of childbearing potential, will strictly adhere to the contraceptive measures mentioned in the protocol.
Exclusion criteria
Exclusion criteria: - Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening. - Has taken an anti-influenza drug within 4 weeks prior to signing the informed consent. - Has received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent. - Has underlying chronic respiratory disease. Subjects with bronchial asthma with asthma symptoms, are currently requiring treatment, or have had an asthma attack in the past year. - At the beginning of the study, is suspected of having bacterial respiratory infection - Has a history of gout or is under treatment for gout or hyperuricemia. - Has hereditary xanthinuria. - Has a history of hypouricemia (under 1 mg/dL) or xanthine calculi of the urinary tract. - Has a history of hypersensitivity to an anti-viral nucleosideanalog drug targeting a viral RNA polymerase. - Is using adrenocorticosteroids or immunosuppressive drugs. - Has an allergy to paracetamol or has a contraindication for paracetamol. - Has a serious chronic disease - Has previously received favipiravir. - Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). - Has a history of alcohol or drug abuse in the preceding 2 years. - Has a psychiatric disease that is not well controlled. - Has taken another investigational drug within 30 days prior to signing the informed consent.
Countries
Argentina, Brazil, Canada, Colombia, Dominican Republic, El Salvador, Guatemala, Mexico, Peru, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed