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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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 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.

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) is a Phase 2 interventional studying Influenza and Acute Respiratory Viral Infection, sponsored by Valenta Pharm JSC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Influenza and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily and personally signed willing to sign a consent form 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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. Exclusion Criteria: 1. Subject's decision to withdraw from the study (withdrawal of informed consent); 2. Investigator's decision to discontinue the subject from the study in the subject's best interest; 3. Investigator-determined need for a concomitant therapy explicitly prohibited by the protocol of clinical study; 4. Subject's use of a therapy prohibited by the protocol; 5. Positive urine test for beta-human chorionic gonadotropin (β-hCG) in females of childbearing potential; 6. Lack of adequate cooperation by the subject with the investigator during the study; 7. 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; 8. Incorrect inclusion of a subject who does not meet the protocol-specified inclusion and/or exclusion criteria; 9. 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); 10. Confirmed diagnosis of COVID-19; 11. Occurrence during the study of any other condition that precludes adherence to the protocol; 12. Subject's death.

Treatments Being Tested

DRUG

Ingavirin Forte, 90 mg + 5 mg, Capsules

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

DRUG

Ingavirin Forte, 90 mg + 10 mg, Capsules

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

DRUG

Ingavirin Forte, 90 mg + 20 mg, Capsules

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

DRUG

Ingavirin, 90 mg, Capsules

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

DRUG

Placebo

1 capsule twice a day, for 5 days

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
"Medical and Diagnostic Center Veris" LLC
Kirov, Russia
State Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"
Moscow, Russia
Unimed-C Jsc
Moscow, Russia
"Professor's Clinic" LLC
Perm, Russia
"Aurora MedFort" LLC
Saint Petersburg, Russia
"Eosmed" LLC
Saint Petersburg, Russia
"OrCli Hospital" LLC
Saint Petersburg, Russia
Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"
Saransk, Russia
"DNA Research Center" LLC
Saratov, Russia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07420985), the sponsor (Valenta Pharm JSC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07420985 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07420985?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07420985?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07420985. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07420985. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.