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).
Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF;
Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR);
Body temperature >38,0 °С at randomization, with no intake NSAID within 12 hours before randomization;
Clinically significant allergic history;
Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;
Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;
Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
Parallel
Ingavirin Forte, 90 mg + 5 mg, Capsules
Drug90 mg + 5 mg, 1 capsule twice a day, for 5 days
Ingavirin Forte, 90 mg + 10 mg, Capsules
Drug90 mg + 10 mg, 1 capsule twice a day, for 5 days
Ingavirin Forte, 90 mg + 20 mg, Capsules
Drug90 mg + 20 mg,1 capsule twice a day, for 5 days
Ingavirin, 90 mg, Capsules
Drug90 mg, 1 capsule twice a day, for 5 days
Placebo
Drug1 capsule twice a day, for 5 days
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).
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 (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).
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.
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.
Safety and Tolerability: adverse events rate
Number and frequency of adverse events and serious adverse events.
Safety and Tolerability: adverse events associated with the study drug
Number and frequency of adverse events associated with the study drug.
Safety and Tolerability: serious adverse events associated with the study drug
Number and frequency of serious adverse events associated with the study drug.
Safety and Tolerability: proportion of subjects with at least one adverse event.
Proportion of subjects with one or more adverse events.
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