Influenza
Conditions
Interventions
Sponsors
Chiba University Hospital
Shionogi Co. Ltd. Japan Institute for Health Security
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals who have completed junior high school or are aged 16 to 80 years at the time of consent. 2) Individuals who have a positive influenza rapid diagnostic test (RAT) using a nasal or nasopharyngeal swab on the day of consent. 3) Individuals who are within four days of the onset of symptoms, counting the first day as the first day. The onset date is defined as any of the following: a. The day on which the body temperature first rose (a rise of 1 oC or more above normal). b. The day on which the patient experienced at least one systemic symptom (fever or chills, muscle or joint pain, fatigue) or respiratory symptom (cough, sore throat, headache, runny nose/stuffy nose). 4) Individuals who have received a thorough explanation of this study and provided their own voluntary written consent with a full understanding.
Exclusion criteria
Exclusion criteria: Persons who fall under any of the following 1) Patients who have used excluded or discontinued medications, such as antiviral drugs, within the past seven days. 2) Patients who are using excluded or discontinued medications, such as antiviral drugs, during their treatment with influenza during study participation. 3) Patients diagnosed with COVID-19. 4) Other individuals deemed inappropriate by the principal investigator. The following medications will be excluded or discontinued: I. Drugs that directly inhibit influenza virus replication 1) Neuraminidase inhibitor Oseltamivir, Zanamivir, Laninamivir, Peramivir 2) Cap-dependent endonuclease inhibitors Baloxavir marboxil 3) M2 ion channel inhibitors Amantadine 4) RNA-dependent RNA polymerase inhibitors Favipiravir II. Drugs with immunosuppressive effects 1) Injectable, oral, inhaled, and nasal corticosteroids (steroids) Prednisolone, Methylprednisolone, Dexamethasone, Hydrocortisone, Fluticasone propionate, and other corticosteroids 2) Injectable and oral calcineurin inhibitors Cyclosporine, Tacrolimus 3) mTOR inhibitors Sirolimus Everolimus 4) Antimetabolites/Antimetabolites Azathioprine, Mycophenolate mofetil, Methotrexate 5) Alkylating agents Cyclophosphamide 6) Immunosuppressive biologics Rituximab, Belimumab, Abatacept, Basiliximab 7) Molecularly targeted drugs such as JAK inhibitors Tofacitinib, Baricitinib, Upadacitinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Threshold value based on logistic regression and ROC analysis using specific antibody titer against influenza virus antigen and success/failure of virus isolation test | — |
Secondary
| Measure | Time frame |
|---|---|
| - Regression analysis using the number of days from symptom onset until virus isolation test negativity and viral RNA negativity and specific antibody (IgG, IgA, secretory IgA) responses to influenza antigens - Analysis of the relationship between host RNA and influenza virus viral load and mucosal antibody titers | — |
Countries
Japan
Contacts
Public ContactMorio Nagira
Chiba University Hospital Department of Human Mucosal Vaccines
Outcome results
None listed