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NCT Number: NCT07420985

Study to Evaluate the Efficacy, Safety, and Tolerability of the Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.

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).

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Key information

Conditions

Influenza Acute Respiratory Viral Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital", Ivanovo, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 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).
  • Duration of illness from symptoms onset to administration of the first dose of investigational medical product or comparator is ≤ 48 hours;
  • No clinical indications for hospitalization at the time of study enrollment;
  • 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

  • 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;
  • 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;
  • Nasal obstruction due to structural pathology, such as sequelae of nasal trauma, nasal polyps, septal deviation, or other organic causes;
  • History of vasomotor rhinitis;
  • 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;
  • Vaccination within 90 days prior to study enrollment;
  • Uncontrolled diabetes mellitus;
  • Obesity, class II or III (body mass index ≥35 kg/m²);
  • Pregnancy or lactation;
  • Positive test for SARS-CoV-2 at screening;
  • History of autoimmune diseases;
  • Current or past HIV, syphilis, hepatitis B and/or C, or tuberculosis;
  • Known or suspected history of alcohol, psychotropic drug, or substance abuse or dependence;
  • 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;
  • Chronic heart failure, New York Heart Association (NYHA) functional class III or IV;
  • Current or past psychiatric disoder;
  • 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;
  • 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;
  • Participation in another clinical trial within 3 months prior to screening;
  • Other conditions which, in the judgment of the investigator, could compromise the subject's participation in the study or pose an undue risk.

Exclusion criteria

  • Subject's decision to withdraw from the study (withdrawal of informed consent);
  • Investigator's decision to discontinue the subject from the study in the subject's best interest;
  • Investigator-determined need for a concomitant therapy explicitly prohibited by the protocol of clinical study;
  • Subject's use of a therapy prohibited by the protocol;
  • Positive urine test for beta-human chorionic gonadotropin (β-hCG) in females of childbearing potential;
  • Lack of adequate cooperation by the subject with the investigator during the study;
  • Emergence during the study of conditions or events that jeopardize subject safety (e.g., hypersensitivity reactions, serious adverse events [SAEs]) or, in the investigator's medical judgment, worsen the subject's prognosis or preclude further participation in the clinical study;
  • Incorrect inclusion of a subject who does not meet the protocol-specified inclusion and/or exclusion criteria;
  • Major deviation from the treatment regimen, defined as:
  • Missing two or more consecutive doses of the investigational medicinal product (IMP) or comparator;
  • Total intake of fewer than 80% or more than 120% of the planned total number of capsules (full course includes 10 capsules);
  • Confirmed diagnosis of COVID-19;
  • Occurrence during the study of any other condition that precludes adherence to the protocol;
  • Subject's death.

Treatment and study plan

Ingavirin Forte, 90 mg + 5 mg, Capsules

Drug

90 mg + 5 mg, 1 capsule twice a day, for 5 days

Other names: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid

Ingavirin Forte, 90 mg + 10 mg, Capsules

Drug

90 mg + 10 mg, 1 capsule twice a day, for 5 days

Other names: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid

Ingavirin Forte, 90 mg + 20 mg, Capsules

Drug

90 mg + 20 mg,1 capsule twice a day, for 5 days

Other names: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid

Ingavirin, 90 mg, Capsules

Drug

90 mg, 1 capsule twice a day, for 5 days

Other names: Imidazolyl ethanamide pentandioic acid

Placebo

Drug

1 capsule twice a day, for 5 days

Primary outcomes

  1. 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):

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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).

  2. Time (in hours) from first dose of study drug to resolution of disease symptoms.

    Time frame: 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).

  3. Proportion of subjects using intranasal decongestant spray for nasal obstruction relief at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: Day 3, Day 6 of the study.

    Rate of nasal decongestant spray use for symptomatic relief of nasal obstruction.

  4. Mean daily frequency of decongestant nasal spray use at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: 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.

  5. Proportion of subjects using analgesic and/or NSAID medications at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: Day 3, Day 6

    Rate of using analgesic and/or NSAID medications to relif symptoms of Influenza or ARVI.

  6. Mean daily frequency of analgesic and/or NSAID use at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: 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.

  7. Proportion of subjects with viral elimination by Visit 3 (Day 6).

    Time frame: Day 6 of the study.

    Proportion of subjects with a negative PCR test result

  8. Assessment of clinical sign severity via pharyngoscopy at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: 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.

  9. Assessment of clinical sign severity via rhinoscopy at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: 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.

  10. Assessment of treatment effectiveness by the Investigator on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: 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.

  11. Subject's assessment of treatment effectiveness on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6).

    Time frame: 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.

Other outcomes

  1. Safety and Tolerability: adverse events rate

    Time frame: Screening (Day-1), and from Day 1 to Day 10

    Number and frequency of adverse events and serious adverse events.

  2. Safety and Tolerability: adverse events associated with the study drug

    Time frame: From Day 1 to Day 10

    Number and frequency of adverse events associated with the study drug.

  3. Safety and Tolerability: serious adverse events associated with the study drug

    Time frame: From Day 1 to Day 10

    Number and frequency of serious adverse events associated with the study drug.

  4. Safety and Tolerability: proportion of subjects with at least one adverse event.

    Time frame: Screening (Day-1), and from Day 1 to Day 10

    Proportion of subjects with one or more adverse events.

  5. Safety and Tolerability: treatment discontinuation

    Time frame: From Day 1 to Day 10

    roportion of subjects who discontinued treatment due to an adverse events.

  6. Safety and Tolerability: vital signs - systolic blood pressure (SBP)

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    SBP, mmHg

  7. Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    DBP, mmHg

  8. Safety and Tolerability: vital signs - respiratory rate (RR)

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    RR, breaths per minute

  9. Safety and Tolerability: vital signs - body temperature

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    Body temperature, Celsius temperature scale

  10. Subject complaints

    Time frame: Screening (Day-1), and from Day 1 to Day 10

    Description of complaints, recieved from subject

  11. Physical examination results - cardiovascular system

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)

  12. Physical examination results - respiratory system

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)

  13. Physical examination results - digestive tract

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)

  14. Physical examination results - endocrine system

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)

  15. Physical examination results - musculoskeletal system

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)

  16. Physical examination results - nervous system

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)

  17. Physical examination results - skin/visible mucous membranes

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)

  18. Physical examination results - genitourinary system

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the genitourinary system on physical examination (normal condition or list of abnormal conditions, if any)

  19. Physical examination results - otorhinolaryngological organs

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the otorhinolaryngological organs on physical examination (normal condition or list of abnormal conditions, if any)

  20. Physical examination results - organ of vision

    Time frame: Screening, Day 1, Day 3, Day 6, and Day 10 of the study.

    An assessment of the condition of the organ of vision on physical examination (normal condition or list of abnormal conditions, if any)

  21. Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)

  22. Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)

  23. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)

  24. Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)

  25. Safety and Tolerability: complete blood count - hemoglobin

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Hemoglobin, g/dL

  26. Safety and Tolerability: complete blood count - hematocrit

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Hematocrit, %

  27. Safety and Tolerability: complete blood count - red blood cells

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Red blood cell count (cells/L)

  28. Safety and Tolerability: clinical blood test - leukocyte count

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Leukocyte count (cells/L)

  29. Safety and Tolerability: clinical blood test - platelet count

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Platelet count (cells/L)

  30. Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Erythrocyte sedimentation rate (mm/h)

  31. Safety and Tolerability: clinical blood test - band neutrophils

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Leukocyte formula (band neutrophils, %)

  32. Safety and Tolerability: clinical blood test - segmented neutrophils

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Leukocyte formula (segmented neutrophils, %)

  33. Safety and Tolerability: clinical blood test - eosinophils

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Leukocyte formula (eosinophils, %)

  34. Safety and Tolerability: clinical blood test - basophils

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Leukocyte formula (basophils, %)

  35. Safety and Tolerability: clinical blood test - monocytes

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Leukocyte formula (monocytes, %)

  36. Safety and Tolerability: clinical blood test - lymphocyte

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    eukocyte formula (lymphocytes, %)

  37. Safety and Tolerability: blood chemistry - alanine transaminase

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Alanine transaminase activity (U/L)

  38. Safety and Tolerability: blood chemistry - aspartate transaminase

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Aspartate transaminase activity (U/L)

  39. Safety and Tolerability: blood chemistry - bilirubin

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Total bilirubin concentration (micromol/L)

  40. Safety and Tolerability: blood chemistry - glucose

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Glucose concentration (mmol/L)

  41. Safety and Tolerability: blood chemistry - total protein

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Total protein in blood serum (g/L)

  42. Safety and Tolerability: blood chemistry - creatinine

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Creatinine concentration (micromol/L)

  43. Safety and Tolerability: blood chemistry - urea

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Urea in blood serum (mmol/L)

  44. C-reactive protein (CRP)

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Serum C-reactive protein (mg/L))

  45. Safety and Tolerability: urinalysis - pH

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    pH of the urine

  46. Safety and Tolerability: urinalysis - specific gravity

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Specific gravity of the urine

  47. Safety and Tolerability: urinalysis - protein

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Protein concentration (g/L)

  48. Safety and Tolerability: urinalysis - glucose

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Glucose concentration (mmol/L)

  49. Safety and Tolerability: urinalysis - red blood cells

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    Red blood cell content (number in sight)

  50. Safety and Tolerability: urinalysis - white blood cells

    Time frame: Screening, Day 3, Day 6, and Day 10 of the study.

    White blood cell content (number in sight)

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Registry information

Official study title

A Multicenter, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of the Investigational Product Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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