The objective of this study is to investigate the efficacy, safety, and tolerability of investigational product Ingavirin forte capsules (Valenta Pharm JSC) administered at different doses compared with medicinal product Ingavirin, 90 mg, capsules (Valenta Pharm JSC) in subjects with influenza or other acute respiratory viral infections (ARVIs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
90 mg + 5 mg, 1 capsule twice a day, for 5 days
90 mg + 10 mg, 1 capsule twice a day, for 5 days
90 mg + 20 mg,1 capsule twice a day, for 5 days
90 mg, 1 capsule twice a day, for 5 days
1 capsule twice a day, for 5 days
Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"
Ivanovo, Russia
RECRUITINGFederal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, Russia
RECRUITING"Medical and Diagnostic Center Veris" LLC
Kirov, Russia
RECRUITINGState Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"
Moscow, Russia
RECRUITINGUnimed-C Jsc
Moscow, Russia
RECRUITING"Professor's Clinic" LLC
Perm, Russia
RECRUITING"Aurora MedFort" LLC
Saint Petersburg, Russia
RECRUITING"Eosmed" LLC
Saint Petersburg, Russia
RECRUITING"OrCli Hospital" LLC
Saint Petersburg, Russia
RECRUITINGFederal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"
Saransk, Russia
RECRUITING...and 1 more locations
Time (in hours) from the first dose of the study drug to the sustained resolution of all the following symptoms/events (with each resolved symptom/event persisting for at least 24 hours without the use of NSAIDs and/or decongestants):
* fever (the first time point at which body temperature remains stably normalized (\<37.0°C) for 24 h); * runny nose/rhinorrhoea (the first time point with Numeric Rating Scale (NRS) ≤ 2 which maintained for ≥24 h); * nasal congestion/stuffiness (the first time point with NRS ≤ 2 which maintained for ≥24 h); * sore throat (the first time point with NRS ≤ 2 which maintained for ≥24 h); * throat irritation (the first time point with NRS ≤ 2 which maintained for ≥24 h); * cough (the first time point with NRS ≤ 2 which maintained for ≥24 h); * generalized weakness/malaise (the first time point with NRS ≤ 2 which maintained for ≥24 h); * headache (the first time point with NRS ≤ 2 which maintained for ≥24 h); * myalgia (the first time point with NRS ≤ 2 which maintained for ≥24 h).
Time frame: Day 1 - Day 10 of the study.
Mean daily symptom severity score based on the NRS (arithmetic mean of the scores over a 24-hour period). A "day" will be calculated as 24-hour intervals starting from the time of the first dose administration.
* fever (arithmetic mean of the daily scores); * runny nose/rhinorrhoea (arithmetic mean of the daily scores); * nasal congestion/stuffiness (arithmetic mean of the daily scores); * sore throat (arithmetic mean of the daily scores); * throat irritation (arithmetic mean of the daily scores); * cough (arithmetic mean of the daily scores); * generalized weakness/malaise (arithmetic mean of the daily scores); * headache (arithmetic mean of the daily scores); * myalgia (arithmetic mean of the daily scores).
Time frame: Day 1 - Day 10 of the study.
Time (in hours) from first dose of study drug to resolution of disease symptoms.
* fever (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * runny nose/rhinorrhoea (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * nasal congestion/stuffiness (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * sore throat (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * throat irritation (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * cough (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * generalized weakness/malaise (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * headache (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h); * myalgia (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h).
Time frame: Day 1 - Day 10 of the study.
Proportion of subjects using intranasal decongestant spray for nasal obstruction relief at Visit 2 (Day 3) and Visit 3 (Day 6).
Rate of nasal decongestant spray use for symptomatic relief of nasal obstruction.
Time frame: Day 3, Day 6 of the study.
Mean daily frequency of decongestant nasal spray use at Visit 2 (Day 3) and Visit 3 (Day 6).
The mean daily frequency of decongestant use will be calculated for each subject as the total number of administrations from the first dose of the investigational product up to the target visit, divided by the number of days in that period.
Time frame: Day 3, Day 6 of the study.
Proportion of subjects using analgesic and/or NSAID medications at Visit 2 (Day 3) and Visit 3 (Day 6).
Rate of using analgesic and/or NSAID medications to relif symptoms of Influenza or ARVI.
Time frame: Day 3, Day 6
Mean daily frequency of analgesic and/or NSAID use at Visit 2 (Day 3) and Visit 3 (Day 6).
The mean daily frequency of analgesic and/or NSAID use will be calculated for each subject as the total number of administrations from the first dose of the investigational product up to the target visit, divided by the number of days in that period.
Time frame: Day 3, Day 6 of the study.
Proportion of subjects with viral elimination by Visit 3 (Day 6).
Proportion of subjects with a negative PCR test result
Time frame: Day 6 of the study.
Assessment of clinical sign severity via pharyngoscopy at Visit 2 (Day 3) and Visit 3 (Day 6).
* Assessment of the severity of hyperemia and ridge-like thickening of the edges of the palatine arches; * Assessment of the severity of caseous-purulent plugs or liquid pus in the tonsillar lacunae; * Assessment of the severity of edema of the tonsils; * Assessment of the severity of edema of the palatine arches; * Assessment of the severity of edema of the uvula; * Assessment of the severity of edema of the posterior pharyngeal wall. Each symptom will be assessed on a 4-point severity scale, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom.
Time frame: Day 3, Day 6 of the study.
Assessment of clinical sign severity via rhinoscopy at Visit 2 (Day 3) and Visit 3 (Day 6).
* Assessment of the severity of nasal discharge * Assessment of the severity of nasal mucosal hyperemia * Assessment of the severity of nasal mucosal edema Each symptom will be assessed on a 4-point severity scale, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom.
Time frame: Day 3, Day 6 of the study.
Assessment of treatment effectiveness by the Investigator on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6).
A 5-point scale will be used to assess treatment effectiveness, where: 1 point - absence of clinical symptoms, 2 points - regression of the main clinical symptoms, 3 points - reduction in the severity of clinical symptoms, 4 points - lack of positive dynamics of clinical symptoms, 5 points - worsening of clinical symptoms.
Time frame: Day 3, Day 6 of the study.
Subject's assessment of treatment effectiveness on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6).
To assess treatment effectiveness from the subject's perspective, a 5-point scale will be used, where: 1 point - poor, 2 points - satisfactory, 3 points - good, 4 points - very good, 5 points - excellent.
Time frame: Day 3, Day 6 of the study.
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