Acute Respiratory Viral Infection, Influenza
Conditions
Brief summary
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).
Interventions
DRUGIngavirin Forte, 90 mg + 5 mg, Capsules
90 mg + 5 mg, 1 capsule twice a day, for 5 days
DRUGIngavirin Forte, 90 mg + 10 mg, Capsules
90 mg + 10 mg, 1 capsule twice a day, for 5 days
DRUGIngavirin Forte, 90 mg + 20 mg, Capsules
90 mg + 20 mg,1 capsule twice a day, for 5 days
DRUGIngavirin, 90 mg, Capsules
90 mg, 1 capsule twice a day, for 5 days
DRUGPlacebo
1 capsule twice a day, for 5 days
Sponsors
Valenta Pharm JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure; 2. Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF; 3. Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR); 4. Presence of clinically significant signs of influenza or acute respiratory viral infections at screening: * Body temperature \>38,0 °С at randomization, with no intake NSAID within 12 hours before randomization; * Presence of at least two of the following symptoms of influenza or other acute respiratory viral infections (cough, rhinorrhea, sore throat, or a throat irritation) each rated non less than 6 points on a numeric rating scale (NRS); * Presence of at least one of the following systemic manifestations of influenza or other acute respiratory viral infections (headache, myalgia, or general weakness) rated non less than 6 points on a numeric rating scale (NRS). 5. Duration of illness from symptoms onset to administration of the first dose of investigational medical product or comparator is ≤ 48 hours; 6. No clinical indications for hospitalization at the time of study enrollment; 7. Consent to use adequate contraceptive methods throughout the study and for 30 days after study completion. The follwing subjects are eligible for inclusion in the study: * Females of childbearing potential must have a negative pregnancy test and use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives, contraceptive subdermal implant, intrauterine hormonal system, intrauterine device. Females not of childbearing potential (i.e., with a history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, comfirmed infertility, or ≥ 2 of menopause) are also eligible for participation; * Males with reptoductive potential must use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives. Males with infertility or a history of vasectomy are also eligible for participation;
Exclusion criteria
1. Clinically significant allergic history; 2. Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator; 3. Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator; 4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption; 5. Clinical suspicion of pneumonia of any etiology, or other bacterial infection (e.g. sinusitis, otitis media, urinary tract infection, meningitis, sepsis) requiring initiation for antibacterial therapy; 6. Nasal obstruction due to structural pathology, such as sequelae of nasal trauma, nasal polyps, septal deviation, or other organic causes; 7. History of vasomotor rhinitis; 8. Administration of antibiotics, antiviral (including Ingavirin), or immunomodulatory agents within 48 hours prior to study, and/or anticipated need for any of these agents during the study; 9. Vaccination within 90 days prior to study enrollment; 10. Uncontrolled diabetes mellitus; 11. Obesity, class II or III (body mass index ≥35 kg/m²); 12. Pregnancy or lactation; 13. Positive test for SARS-CoV-2 at screening; 14. History of autoimmune diseases; 15. Current or past HIV, syphilis, hepatitis B and/or C, or tuberculosis; 16. Known or suspected history of alcohol, psychotropic drug, or substance abuse or dependence; 17. History of chronic respiratory disease, including but not limited to: chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, diffuse panbronchiolitis, pulmonary emphysema, or pulmonary fibrosis; 18. Chronic heart failure, New York Heart Association (NYHA) functional class III or IV; 19. Current or past psychiatric disoder; 20. Any clinically significant cardiovascular, renal, hepatic, gastrointestinal , endocrine, or neurological disoder, including severe uncompensated chronic conditions (e.g., chronic kidney disease, chronic liver disease) or acute illness, or any other medical or psychiatric condition that, in investigator's opinion, could pose a safety risk to the subject if they participate in the study; 21. Subject's refusal to use an adequate method of contraception or to practice continuous sexual abstinence throughout the study and for 30 days after study completion; 22. Participation in another clinical trial within 3 months prior to screening; 23. Other conditions which, in the judgment of the investigator, could compromise the subject's participation in the study or pose an undue risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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): | Day 1 - Day 10 of the study. | * 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 - Day 10 of the study. | * 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. | Day 1 - Day 10 of the study. | * 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). | Day 3, Day 6 of the study. | 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). | Day 3, Day 6 of the study. | 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. |
| Proportion of subjects using analgesic and/or NSAID medications at Visit 2 (Day 3) and Visit 3 (Day 6). | Day 3, Day 6 | Rate of using analgesic and/or NSAID medications to relif symptoms of Influenza or ARVI. |
| Mean daily frequency of analgesic and/or NSAID use at Visit 2 (Day 3) and Visit 3 (Day 6). | Day 3, Day 6 of the study. | 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. |
| Proportion of subjects with viral elimination by Visit 3 (Day 6). | Day 6 of the study. | Proportion of subjects with a negative PCR test result |
| Assessment of clinical sign severity via pharyngoscopy at Visit 2 (Day 3) and Visit 3 (Day 6). | Day 3, Day 6 of the study. | * 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. |
| Assessment of clinical sign severity via rhinoscopy at Visit 2 (Day 3) and Visit 3 (Day 6). | Day 3, Day 6 of the study. | * 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. |
| Assessment of treatment effectiveness by the Investigator on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6). | Day 3, Day 6 of the study. | 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. |
| Subject's assessment of treatment effectiveness on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6). | Day 3, Day 6 of the study. | 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. |
Countries
Russia
Outcome results
None listed