DMID 21-0041; Influenza CVD 59000

Eligibility Criteria

• * Provides written informed consent, able to comply with the planned study procedures, available for between 2 and 5 days stay in the research quarantine unit for the CHIVITT, and have the ability to attend the scheduled follow-up visits.
• * Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted).
• * Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent.
• * Laboratory-confirmed influenza infection within the past 48 hours at time of entry into the exposure event.
• * Within the past 48 hours at time of entry into the exposure event, onset of influenza-like illness, as defined as fever (measured oral temperature of ≥100.2°F or self-reported fever in the absence of a measured temperature) AND cough or sore throat, or onset of less specific symptoms with a positive molecular test for influenza virus infection
• * No self-reported or known history of alcohol or drug abuse within the past two years and no illicit drug use within the last 30 days.
• * Do not have clinically significant medical, psychiatric, and chronic or intermittent health conditions including those listed in Exclusion Criteria.
• * Does not have an ongoing symptomatic condition for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan.
• * Agrees to the collection of specimens for secondary research.
• * Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon admission to the hotel quarantine unit.
• * Presence of self-reported or medically documented significant medical or psychiatric condition(s)5
• * Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short-acting beta agonists, theophylline, ipratropium, biologics.
• * Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness7.
• * Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.
• * Is a habitual smoker8 of tobacco, marijuana, or e-cigarettes per self-report.
• * Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion.
• * Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to acetaminophen/paracetamol).
• * History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis.
• * Presence of co-infection with SARS-CoV-2, as detected via a multiplex nucleic acid amplification test (e.g., Biofire).
• * Participating in any other interventional clinical research study that has a scheduled intervention 30 days prior to the CHIVITT or 30 after discharge from the research quarantine unit.
• * Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject or the study objectives.