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.

NCT07420985 | Recruiting Phase 2

• 1 other identifier: IFR-02-03-2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 11

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).

Conditions

Influenza; Acute Respiratory Viral Infection

Outcome Measures

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):

  * 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).

  Day 1 - Day 10 of the study.

Secondary Outcomes (11)

• 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.

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

  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).

  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).

  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).

  Day 3, Day 6

Other Outcomes (50)

• Safety and Tolerability: adverse events rate

  Screening (Day-1), and from Day 1 to Day 10

• Safety and Tolerability: adverse events associated with the study drug

  From Day 1 to Day 10

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

  From Day 1 to Day 10

Study Arms (5)

Ingavirin Forte, 90 mg + 5 mg, Capsules

EXPERIMENTAL

Subjects will receive Ingavirin Forte, 90 mg + 5 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.

Drug: Ingavirin Forte, 90 mg + 5 mg, Capsules

Ingavirin Forte, 90 mg + 10 mg, Capsules

EXPERIMENTAL

Subjects will receive Ingavirin Forte, 90 mg + 10 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.

Drug: Ingavirin Forte, 90 mg + 10 mg, Capsules

Ingavirin Forte, 90 mg + 20 mg, Capsules

EXPERIMENTAL

Subjects will receive Ingavirin Forte, 90 mg + 20 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.

Drug: Ingavirin Forte, 90 mg + 20 mg, Capsules

Ingavirin Forte, 90 mg , Capsules

ACTIVE COMPARATOR

Subjects will receive Ingavirin, 90 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.

Drug: Ingavirin, 90 mg, Capsules

Placebo, Capsules

PLACEBO COMPARATOR

Subjects will receive Placebo, 1 capsule twice daily (morning and evening), for 5 consecutive days.

Drug: Placebo

Interventions

Ingavirin Forte, 90 mg + 5 mg, Capsules DRUG

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

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

Ingavirin Forte, 90 mg + 5 mg, Capsules

Ingavirin Forte, 90 mg + 10 mg, Capsules DRUG

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

Also known as: 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

Ingavirin Forte, 90 mg + 20 mg, Capsules DRUG

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

Also known as: 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

Ingavirin, 90 mg, Capsules DRUG

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

Also known as: Imidazolyl ethanamide pentandioic acid

Ingavirin Forte, 90 mg , Capsules

Placebo DRUG

1 capsule twice a day, for 5 days

Placebo, Capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (11)

Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"

Ivanovo, 153025, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation

Kirov, 610027, Russia

RECRUITING

"Medical and Diagnostic Center Veris" LLC

Kirov, 610046, Russia

RECRUITING

State Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"

Moscow, 117042, Russia

RECRUITING

Unimed-C Jsc

Moscow, 119571, Russia

RECRUITING

"Professor's Clinic" LLC

Perm, 614070, Russia

RECRUITING

"Aurora MedFort" LLC

Saint Petersburg, 194156, Russia

RECRUITING

"Eosmed" LLC

Saint Petersburg, 195197, Russia

RECRUITING

"OrCli Hospital" LLC

Saint Petersburg, 199178, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"

Saransk, 430005, Russia

RECRUITING

"DNA Research Center" LLC

Saratov, 410019, Russia

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 19, 2026
• Study Start: October 24, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

RU (11)