Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059938) titled 'Study of Short-term Correlation Between Influenza Virus and Antibodies in Nasal Swabs' on Dec. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Chiba University Hospital

Condition: Condition - Influenza Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to clarify the threshold value of mucosal antibody titer required to suppress virus shedding. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Nasopharyngeal swab collection

Eligibility: Age-lower limit - 16 years-old

Gender - Male and Female Key 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. Key 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 Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 07 Day Anticipated trial start date - 2025 Year 12 Month 10 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068553

Disclaimer: Curated by HT Syndication.