nctId: NCT06286254 id: CYCL-NTTF-2023 briefTitle: Study of Safety and Efficacy of the Drug Cycloferone in Patients With Acute Respiratory Viral Infection overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-20 date: 2024-02-20 date: 2024-07-30 date: 2024-02-29 date: 2024-02-29 name: POLYSAN Scientific & Technological Pharmaceutical Company class: INDUSTRY briefSummary: The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings. conditions: Acute Respiratory Viral Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 742 type: ACTUAL name: Cycloferone measure: Average fever duration according to the data of the Patient's Diary measure: Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire)** measure: Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4 measure: Time (days) till disappearance of disease symptoms according to WURSS-21 scale. measure: Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale. measure: Number of patients with symptoms of disease of different severity degree according to CCQ scale. measure: Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy. measure: Frequency of the need to administer the systemic antibacterial therapy measure: Percentage of patients who needed hospitalization measure: Average duration of the temporary incapacity period. measure: Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen. measure: Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic Zvezdnaya city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical center Astarta city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Energiya Zdoroviy city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Meily city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Oris city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center PiterClinica city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Reavita Med city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center SOGAZ city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Research Center Eco-Safety city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No. 117 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No. 44 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity clinic No.109 city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Сity hospital No. 40 city: Sestroretsk country: Russian Federation lat: 60.09801 lon: 29.96378 hasResults: False