InfluenzaPhase 2NCT07420985
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.
A Phase 2 study testing Ingavirin Forte, 90 mg + 5 mg, Capsules, Ingavirin Forte, 90 mg + 10 mg, Capsules and Ingavirin Forte, 90 mg + 20 mg, Capsules in people with Influenza and Acute Respiratory Viral Infection, run by Valenta Pharm JSC at 11 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza, Acute Respiratory Viral Infection
- What is being tested?
- Ingavirin Forte, 90 mg + 5 mg, Capsules, Ingavirin Forte, 90 mg + 10 mg, Capsules and Ingavirin Forte, 90 mg + 20 mg, Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 11 sitesRussia
- Study dates
- 24 Oct 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 12Show fewer
- 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;
Who cannot join
- 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;
Show all 37Show fewer
- 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.
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Russia11 sites, 11 recruiting
- Recruiting
Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"
Ivanovo, 153025
Svetlana Ushakova, MD, PhD, +7 (910) 992-39-62, svetland1962@mail.ru
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, 610027
Tatiana Chudinovskikh, MD, PhD, +7 (8332) 62-77-28, Tatiana.сhudinovskikh@gmail.com
- Recruiting
"Medical and Diagnostic Center Veris" LLC
Kirov, 610046
Nadezhda Trushnikova, + 7 (8332) 62-75-68, uddefola@mail.ru
- Recruiting
State Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"
Moscow, 117042
Dmitry Bystritsky, +7 (916) 777-24-11, bystritskiida@mail.ru
- Recruiting
Unimed-C Jsc
Moscow, 119571
Elena Volnaya, +7 (495)-135-50-10, drvolnaya@yandex.ru
- Recruiting
"Professor's Clinic" LLC
Perm, 614070
Svetlana Teplykh, MD, PhD, +7 (919) 498-29-31, profkliniki@mail.ru
- Recruiting
"Aurora MedFort" LLC
Saint Petersburg, 194156
Igor Balaban, +7 (921) 903-94-95, igorbalaban.81@mail.ru
- Recruiting
"Eosmed" LLC
Saint Petersburg, 195197
Ekaterina Polyakova, MD,PhD, +7 (812) 988-00-46, polyakova_ea@yahoo.com
- Recruiting
"OrCli Hospital" LLC
Saint Petersburg, 199178
Varvara Popova, MD,PhD, +7 (921) 753-63-81, varvara-pa@mail.ru
- Recruiting
Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"
Saransk, 430005
Natalya Selezneva, MD, PhD, + 7 (8342) 33-34-09, nata_rm@mail.ru
- Recruiting
"DNA Research Center" LLC
Saratov, 410019
Inna Gamova, MD, PhD, +7 (845) 249-43-14, innapris@yandex.ru
About this study
Official 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.
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
- Being tested
- Ingavirin Forte, 90 mg + 5 mg, Capsules, Ingavirin Forte, 90 mg + 10 mg, Capsules, Ingavirin Forte, 90 mg + 20 mg, Capsules, Ingavirin, 90 mg, Capsules, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingavirin Forte, 90 mg + 5 mg, CapsulesDrug
Also called Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid
90 mg + 5 mg, 1 capsule twice a day, for 5 days
Ingavirin Forte, 90 mg + 10 mg, CapsulesDrug
Also called Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid
90 mg + 10 mg, 1 capsule twice a day, for 5 days
Ingavirin Forte, 90 mg + 20 mg, CapsulesDrug
Also called Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid
90 mg + 20 mg,1 capsule twice a day, for 5 days
Ingavirin, 90 mg, CapsulesDrug
Also called Imidazolyl ethanamide pentandioic acid
90 mg, 1 capsule twice a day, for 5 days
PlaceboDrug
1 capsule twice a day, for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Ingavirin, 90 mg, Capsules |
| Placebo, Capsules | Placebo comparator | Subjects will receive Placebo, 1 capsule twice daily (morning and evening), for 5 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
- 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 3, Day 6 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start24 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420985
- Sponsor's protocol ID
- IFR-02-03-2025
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07420985
- Acronym / sponsor ID
- IFR-02-03-2025
- Conditions
- Influenza, Acute Respiratory Viral Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ingavirin Forte, 90 mg + 5 mg, Capsules | Experimental | Drug: Ingavirin Forte, 90 mg + 5 mg, CapsulesSubjects will receive Ingavirin Forte, 90 mg + 5 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days. |
| Ingavirin Forte, 90 mg + 10 mg, Capsules | Experimental | Drug: Ingavirin Forte, 90 mg + 10 mg, CapsulesSubjects will receive Ingavirin Forte, 90 mg + 10 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days. |
| Ingavirin Forte, 90 mg + 20 mg, Capsules | Experimental | Drug: Ingavirin Forte, 90 mg + 20 mg, CapsulesSubjects will receive Ingavirin Forte, 90 mg + 20 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days. |
| Ingavirin Forte, 90 mg , Capsules | Active comparator | Drug: Ingavirin, 90 mg, CapsulesSubjects will receive Ingavirin, 90 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days. |
| Placebo, Capsules | Placebo comparator | Drug: PlaceboSubjects will receive Placebo, 1 capsule twice daily (morning and evening), for 5 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Duration of illness from symptoms onset to administration of the first dose of investigational medical product or comparator is ≤ 48 hours;
Key exclusion criteria (37 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingavirin Forte, 90 mg + 5 mg, CapsulesAlso: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid90 mg + 5 mg, 1 capsule twice a day, for 5 days | Drug | Ingavirin Forte, 90 mg + 5 mg, Capsules |
| Ingavirin Forte, 90 mg + 10 mg, CapsulesAlso: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid90 mg + 10 mg, 1 capsule twice a day, for 5 days | Drug | Ingavirin Forte, 90 mg + 10 mg, Capsules |
| Ingavirin Forte, 90 mg + 20 mg, CapsulesAlso: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid90 mg + 20 mg,1 capsule twice a day, for 5 days | Drug | Ingavirin Forte, 90 mg + 20 mg, Capsules |
| Ingavirin, 90 mg, CapsulesAlso: Imidazolyl ethanamide pentandioic acid90 mg, 1 capsule twice a day, for 5 days | Drug | Ingavirin Forte, 90 mg , Capsules |
| Placebo1 capsule twice a day, for 5 days | Drug | Placebo, Capsules |
Primary outcome
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).
11 secondary outcomes
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.
Time (in hours) from first dose of study drug to resolution of disease symptoms.
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).
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).
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).
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).
Time frame: Day 3, Day 6 of the study.
Proportion of subjects with viral elimination by Visit 3 (Day 6).
Time frame: Day 6 of the study.
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 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 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Related trials for Influenza
Active, not recruitingEarly Phase 1
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Influenza, Human
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"
Ivanovo, Russia
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, Russia
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ingavirin Forte, 90 mg + 5 mg, Capsules, Ingavirin Forte, 90 mg + 10 mg, Capsules and Ingavirin Forte, 90 mg + 20 mg, Capsules in people with Influenza and Acute Respiratory Viral Infection, run by Valenta Pharm JSC at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.