Influenza, HumanPhase 4NCT06315400
Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections
A Phase 4 study testing Ingavirin® in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 3 sites in Russia.
Trial summary
The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Influenza, Human, Acute Respiratory Infection, Common Cold
- What is being tested?
- Ingavirin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesRussia
- Study dates
- 19 Dec 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients aged 13 to 17 years inclusive.
- Clinically established diagnosis of influenza or acute respiratory viral infection based on the presence of body temperature > 37.5 °C and at least 1 of the following symptoms of intoxication syndrome, and at least 1 manifestation of catarrhal syndrome: symptoms of intoxication syndrome (headache, chills, weakness, brokenness, eyeball pain, nausea); catarrhal syndrome (sore throat, rhinitis, pharyngitis, laryngitis, cough).
- Laboratory-confirmed diagnosis of influenza or acute respiratory viral infections using one or more of the following viral antigen detection methods.
- Uncomplicated course of influenza or ARVI.
- Interval between the onset of the first symptoms of the disease and inclusion in the study no more than 36 h.
- Availability of an informed consent form signed by one of the parents (or legal representatives) of the child for participation in the study.
- For patients 14 years and older, a signed informed consent form for participation in the study.
Who cannot join
- Hypersensitivity to any of the components included in the Ingavirin®.
- Complicated course of influenza and acute respiratory viral infections (clinically and laboratory determined bacterial infection).
- Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugs with immunomodulatory effect) or systemic antibacterial agents 7 days prior to the Screening Visit.
- Severe influenza with signs of cardiovascular failure and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions).
- Signs of viral pneumonia (presence of two or more of the following symptoms: dyspnea, chest pain when coughing, systemic cyanosis, dulling of the percussion sound with symmetric evaluation of the upper and lower lungs).
- Infectious diseases suffered during the last week before inclusion of the patient in the study.
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- "Frequently ill children" (frequency of acute respiratory illnesses during the last year 6 times or more).
- A history of bronchial asthma.
- A history of increased seizure activity.
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, as well as make it impossible to conduct a clinical trial in the patient).
- History of oncologic diseases, HIV infection, tuberculosis.
- Diabetes mellitus, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrose/isomaltase deficiency, fructose intolerance, hereditary disorders of glucose absorption, glucose-6-phosphate dehydrogenase deficiency.
- Participation in a clinical drug trial less than 3 months prior to the start of the study.
- Immunization of the patient 14 days prior to the Screening Visit.
- The need for concomitant therapy with any of the drugs listed under "Prohibited Concomitant Treatment".
- Any other concomitant somatic diseases or conditions that, in the opinion of the investigator, make it difficult to interpret the results of treatment or result in the inability to perform the procedures in this clinical trial or pose a risk to the patient in participating in the study.
- For female patients, a positive urine pregnancy test if menstrual cycle is present.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites, 3 recruiting
- Recruiting
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
Rostov-on-Don
Tatiana V Zolotova, Prof., +7-928-1049101, tvzolotova1953@yandex.ru
- Recruiting
GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
Tomsk
Yulia G Samoilova, MD, PhD, +7-3822530127, samoilova_y@inbox.ru
- Recruiting
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl, 150000
Ivan G Sitnikov, Prof., +7-4852-736769, sitnikov@ysmu.ru
About this study
Official title: Double-blind, Multicenter, Randomized, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of Ingavirin®, 60 mg Capsules in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Children Aged 13-17 Years.
The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo.
- Conditions
- Influenza, Human, Acute Respiratory Infection, Common Cold
- Being tested
- Ingavirin®, Placebo
- Medical subject headings
- Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingavirin®Drug
60 mg/day for 5 days
PlaceboDrug
1 capsule/day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Ingavirin®, capsules, 60 mg | Experimental | Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy. Receives: Drug: Ingavirin® |
| Placebo | Placebo comparator | Placebo will be administered once a day for 5 days on top of standard therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with normalization of body temperature at Visit 3 (Day 3)
Percentage of patients with body temperature <37ºС with no rise above these values in the subsequent period until Visit 7
Measured: Day 0 - Day 21±1
Secondary outcomes (30)
Timeframe for normalization of body temperature from the start of treatment, measured in hours
Time (hours) to reach body temperature <37ºС with no rise above these values in the subsequent period until Visit 7 (Day 21±1)
Measured: Day 0 - Day 21±1
Time of cough disappearance from the moment of treatment initiation
Disappearance of cough; no recurrence of cough in the following days of observation
Measured: Day 0 - Day 21±1
Percentage of patients with absence of catarrhal syndrome
Percentage of patients with disappearance of all manifestations; no recurrence on subsequent days of follow-up) at Visit 3 (Day 3)
Measured: Day 0 - Day 21±1
Percentage of patients with absence of intoxication syndrome
Percentage of patients with disappearance of all manifestations; no recurrence on subsequent days of follow-up) at Visit 3 (Day 3)
Measured: Day 0 - Day 21±1
Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy
Average body temperature (two measurements per a day)
Measured: Day 1 - Day 5
Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Percentage of patients with at least one complication of disease
Measured: Day 0 - Day 21±1
Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Percentage of patients with at least one severe complication of disease
Measured: Day 0 - Day 21±1
Assessment of vital signs: blood pressure
Blood pressure, mmHg
Measured: Day 1, Day 3, Day 6
Assessment of vital signs: heart rate
Heart rate, bpm
Measured: Day 1, Day 3, Day 6
Assessment of vital signs: respiratory rate
Respiratory rate, bpm
Measured: Day 1, Day 3, Day 6
Assessment of vital signs: body temperature
Temperature, ºС
Measured: Day 1 - Day 6
Evaluation of concomitant therapy
Number and types of concomitant therapy
Measured: Day 0 - Day 21±1
Laboratory evaluation: leukocyte formula
Precentage of white blood cells of different types
Measured: Day 1, Day 6
Laboratory evaluation: hemoglobin
Hemoglobin, g/L
Measured: Day 1, Day 6
Laboratory evaluation: leukocyte count
Cell/mL
Measured: Day 1, Day 6
Laboratory evaluation: platelet count
Cell/mL
Measured: Day 1, Day 6
Laboratory evaluation: red blood cell count
Cell/mL
Measured: Day 1, Day 6
Laboratory evaluation: hematocrit
Hematocrit, %
Measured: Day 1, Day 6
Laboratory evaluation: erythrocyte sedimentation rate
mm/h
Measured: Day 1, Day 6
Laboratory evaluation: blood glucose
mmol/L
Measured: Day 1, Day 6
Laboratory evaluation: total protein
g/L
Measured: Day 1, Day 6
Laboratory evaluation: total bilirubin
mcmol/L
Measured: Day 1, Day 6
Laboratory evaluation: AST
U/L
Measured: Day 1, Day 6
Laboratory evaluation: ALT
U/L
Measured: Day 1, Day 6
Laboratory evaluation: creatinine
mcmol/L
Measured: Day 1, Day 6
Laboratory evaluation: urea
mmol/L
Measured: Day 1, Day 6
Laboratory evaluation: triglycerides
mmol/L
Measured: Day 1, Day 6
Laboratory evaluation: urinalysis
Urune color, transparency, specific gravity, pH, presence of protein, glucose, bilirubin, microscopy of urine sediment (epithelium, erythrocytes, leukocytes, cylinders, bacteria, salts)
Measured: Day 1, Day 6
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Total number and frequency of AEs and SAEs stratified by severity and frequency
Measured: Day 0 - Day 21±1
Percentage of patients who discontinued study due to AE/SAE
Percentage of patients who discontinued study participation early due to the occurrence of AE/SAE and time to dropout due to AE/SAE
Measured: Day 0 - Day 21±1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start19 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT06315400
- Sponsor's protocol ID
- ING-07-2023
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Multicenter, Randomized, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of Ingavirin®, 60 mg Capsules in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Children Aged 13-17 Years.
- ClinicalTrials.gov ID
- NCT06315400
- Acronym / sponsor ID
- ING-07-2023
- Conditions
- Influenza, Human, Acute Respiratory Infection, Common Cold
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Mar 2024 (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 study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingavirin®, capsules, 60 mg | Experimental | Drug: Ingavirin®Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered once a day for 5 days on top of standard therapy. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male and female patients aged 13 to 17 years inclusive.
- Clinically established diagnosis of influenza or acute respiratory viral infection based on the presence of body temperature > 37.5 °C and at least 1 of the following symptoms of intoxication syndrome, and at least 1 manifestation of catarrhal syndrome: symptoms of intoxication syndrome (headache, chills, weakness, brokenness, eyeball pain, nausea); catarrhal syndrome (sore throat, rhinitis, pharyngitis, laryngitis, cough).
- Laboratory-confirmed diagnosis of influenza or acute respiratory viral infections using one or more of the following viral antigen detection methods.
- Uncomplicated course of influenza or ARVI.
- Interval between the onset of the first symptoms of the disease and inclusion in the study no more than 36 h.
Key exclusion criteria (17 listed)
- Hypersensitivity to any of the components included in the Ingavirin®.
- Complicated course of influenza and acute respiratory viral infections (clinically and laboratory determined bacterial infection).
- Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugs with immunomodulatory effect) or systemic antibacterial agents 7 days prior to the Screening Visit.
- Severe influenza with signs of cardiovascular failure and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions).
- Signs of viral pneumonia (presence of two or more of the following symptoms: dyspnea, chest pain when coughing, systemic cyanosis, dulling of the percussion sound with symmetric evaluation of the upper and lower lungs).
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®60 mg/day for 5 days | Drug | Ingavirin®, capsules, 60 mg |
| Placebo1 capsule/day for 5 days | Drug | Placebo |
Primary outcome
Percentage of patients with normalization of body temperature at Visit 3 (Day 3)
Time frame: Day 0 - Day 21±1
Percentage of patients with body temperature <37ºС with no rise above these values in the subsequent period until Visit 7
30 secondary outcomes
Timeframe for normalization of body temperature from the start of treatment, measured in hours
Time frame: Day 0 - Day 21±1
Time of cough disappearance from the moment of treatment initiation
Time frame: Day 0 - Day 21±1
Percentage of patients with absence of catarrhal syndrome
Time frame: Day 0 - Day 21±1
Percentage of patients with absence of intoxication syndrome
Time frame: Day 0 - Day 21±1
Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy
Time frame: Day 1 - Day 5
Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Time frame: Day 0 - Day 21±1
Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Time frame: Day 0 - Day 21±1
Assessment of vital signs: blood pressure
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: heart rate
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: respiratory rate
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: body temperature
Time frame: Day 1 - Day 6
Evaluation of concomitant therapy
Time frame: Day 0 - Day 21±1
Laboratory evaluation: leukocyte formula
Time frame: Day 1, Day 6
Laboratory evaluation: hemoglobin
Time frame: Day 1, Day 6
Laboratory evaluation: leukocyte count
Time frame: Day 1, Day 6
Laboratory evaluation: platelet count
Time frame: Day 1, Day 6
Laboratory evaluation: red blood cell count
Time frame: Day 1, Day 6
Laboratory evaluation: hematocrit
Time frame: Day 1, Day 6
Laboratory evaluation: erythrocyte sedimentation rate
Time frame: Day 1, Day 6
Laboratory evaluation: blood glucose
Time frame: Day 1, Day 6
Laboratory evaluation: total protein
Time frame: Day 1, Day 6
Laboratory evaluation: total bilirubin
Time frame: Day 1, Day 6
Laboratory evaluation: AST
Time frame: Day 1, Day 6
Laboratory evaluation: ALT
Time frame: Day 1, Day 6
Laboratory evaluation: creatinine
Time frame: Day 1, Day 6
Laboratory evaluation: urea
Time frame: Day 1, Day 6
Laboratory evaluation: triglycerides
Time frame: Day 1, Day 6
Laboratory evaluation: urinalysis
Time frame: Day 1, Day 6
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 0 - Day 21±1
Percentage of patients who discontinued study due to AE/SAE
Time frame: Day 0 - Day 21±1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
Rostov-on-Don, Russia
GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
Tomsk, Russia
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl, Russia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ingavirin® in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 3 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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Percentage of patients with normalization of body temperature at Visit 3 (Day 3) (time frame: Day 0 - Day 21±1). 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 1 Apr 2024.