Actively Recruiting
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.
Led by Valenta Pharm JSC · Updated on 2026-02-19
300
Participants Needed
11
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent before any study procedure
- Males and females aged 18 to 65 years at consent
- Influenza or other acute respiratory viral infections confirmed by PCR
- Fever over 38.0 °C at randomization without NSAID use within 12 hours
- At least two symptoms (cough, runny nose, sore throat, throat irritation) with severity of 6 or more on a numeric scale
- At least one systemic symptom (headache, muscle pain, or general weakness) rated 6 or more
- Illness duration from symptom start to first dose is 48 hours or less
- No clinical need for hospitalization at enrollment
- Agreement to use effective contraception during the study and for 30 days after completion, with specific contraceptive methods for females and males as described
- Females not of childbearing potential with confirmed infertility or surgical sterilization are eligible
You will not qualify if you...
- Significant allergy history
- Hypersensitivity or intolerance to Ingavirin, Ingavirin Forte, or any excipients
- Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- Clinical suspicion of pneumonia or bacterial infections needing antibiotics
- Nasal obstruction from structural causes
- History of vasomotor rhinitis
- Use of antibiotics, antivirals, or immunomodulators within 48 hours before study or anticipated need during study
- Vaccination within 90 days before enrollment
- Uncontrolled diabetes
- Obesity class II or III (BMI ≥35 kg/m²)
- Pregnancy or breastfeeding
- Positive SARS-CoV-2 test at screening
- History of autoimmune diseases
- Current or past HIV, syphilis, hepatitis B or C, or tuberculosis
- History of substance abuse or dependence
- Chronic respiratory diseases including COPD, asthma, bronchitis, emphysema, or fibrosis
- Severe chronic heart failure (NYHA class III or IV)
- Current or past psychiatric disorders
- Significant cardiovascular, renal, hepatic, gastrointestinal, endocrine, neurological disorders or severe acute illness
- Refusal or inability to use adequate contraception or abstain from sex during study and 30 days after
- Participation in another clinical trial within 3 months prior to screening
- Any other conditions judged by investigator to risk safety or participation
- Withdrawal of consent or investigator decision to discontinue
- Use of prohibited therapies
- Positive pregnancy test in females of childbearing potential
- Poor cooperation with study procedures
- Major deviations from treatment regimen
- Confirmed COVID-19 diagnosis
- Any condition during study that prevents protocol adherence
- Death of the participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"
Ivanovo, Russia, 153025
Actively Recruiting
2
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, Russia, 610027
Actively Recruiting
3
"Medical and Diagnostic Center Veris" LLC
Kirov, Russia, 610046
Actively Recruiting
4
State Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"
Moscow, Russia, 117042
Actively Recruiting
5
Unimed-C Jsc
Moscow, Russia, 119571
Actively Recruiting
6
"Professor's Clinic" LLC
Perm, Russia, 614070
Actively Recruiting
7
"Aurora MedFort" LLC
Saint Petersburg, Russia, 194156
Actively Recruiting
8
"Eosmed" LLC
Saint Petersburg, Russia, 195197
Actively Recruiting
9
"OrCli Hospital" LLC
Saint Petersburg, Russia, 199178
Actively Recruiting
10
Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"
Saransk, Russia, 430005
Actively Recruiting
11
"DNA Research Center" LLC
Saratov, Russia, 410019
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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