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New pill aims to knock out flu symptoms faster
NCT ID NCT07420985
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a higher-dose version of the drug Ingavirin can help adults with the flu or other viral infections feel better faster. About 300 people will receive either the study drug or a placebo. The main goal is to see how quickly symptoms like fever, cough, and sore throat go away and stay away for at least 24 hours.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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"Aurora MedFort" LLC
RECRUITINGSaint Petersburg, 194156, Russia
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"DNA Research Center" LLC
RECRUITINGSaratov, 410019, Russia
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"Eosmed" LLC
RECRUITINGSaint Petersburg, 195197, Russia
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"Medical and Diagnostic Center Veris" LLC
RECRUITINGKirov, 610046, Russia
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"OrCli Hospital" LLC
RECRUITINGSaint Petersburg, 199178, Russia
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"Professor's Clinic" LLC
RECRUITINGPerm, 614070, Russia
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Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
RECRUITINGKirov, 610027, Russia
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Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"
RECRUITINGSaransk, 430005, Russia
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Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"
RECRUITINGIvanovo, 153025, Russia
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State Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"
RECRUITINGMoscow, 117042, Russia
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Unimed-C Jsc
RECRUITINGMoscow, 119571, Russia
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