protocolSection identificationModule nctId: NCT06286254, orgStudyIdInfo id: CYCL-NTTF-2023, briefTitle: Study of Safety and Efficacy of the Drug Cycloferone in Patients With Acute Respiratory Viral Infection, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: POLYSAN Scientific & Technological Pharmaceutical Company, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Acute Respiratory Viral Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 742, type: ACTUAL, armsInterventionsModule interventions name: Cycloferone, outcomesModule primaryOutcomes measure: Average fever duration according to the data of the Patient's Diary, secondaryOutcomes 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)**, secondaryOutcomes measure: Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4, secondaryOutcomes measure: Time (days) till disappearance of disease symptoms according to WURSS-21 scale., secondaryOutcomes measure: Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale., secondaryOutcomes measure: Number of patients with symptoms of disease of different severity degree according to CCQ scale., secondaryOutcomes measure: Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy., secondaryOutcomes measure: Frequency of the need to administer the systemic antibacterial therapy, secondaryOutcomes measure: Percentage of patients who needed hospitalization, secondaryOutcomes measure: Average duration of the temporary incapacity period., secondaryOutcomes 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., secondaryOutcomes 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., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic Zvezdnaya, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical center Astarta, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Energiya Zdoroviy, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Meily, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Oris, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center PiterClinica, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Reavita Med, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center SOGAZ, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Research Center Eco-Safety, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity clinic No. 117, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity clinic No. 44, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity clinic No.109, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity hospital No. 40, city: Sestroretsk, country: Russian Federation, geoPoint lat: 60.09801, lon: 29.96378, hasResults: False