Influenza, HumanPhase 3NCT05269290

Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections

A Phase 3 study testing Ingavirin®, syrup, 30 mg/5 ml in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 8 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, syrup, 30 mg/5 ml, in the treatment of influenza or other acute respiratory infections in children from 6 months to 2 years compared with placebo. Read more about this study

Who is it for?: Ages 6 months to 2 years
Conditions the study is for: Influenza, Human, Acute Respiratory Infection, Common Cold
What is being tested?: Ingavirin®, syrup, 30 mg/5 ml
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 8 sitesRussia
Study dates: 23 Sep 2021to 15 Jul 2022
Phase: Phase 3
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 6 months to 2 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patient's parent/adoptive parent's informed consent form voluntarily signed by the patient's parent/adoptive parent;
Boys and girls aged 6 months - 2 years 11 months 14 days, inclusive, with the following clinical signs of acute respiratory infections/flu: body temperature above 38.0 °C but not higher than 39.0 °C (without taking antipyretics within the last 8 h) at the time of screening/randomization; at least one of the respiratory manifestations of acute respiratory infection/influenza (cough, runny nose/ stuffy nose) of at least 2 points on a 4-point scale; decrease in the child's daytime activity and change in nighttime sleep, as compared with the state before the illness;
There were no indications for hospitalization at the time of inclusion in the study;
Duration of illness from manifestation of symptoms to inclusion in the study not more than 48 hours.

Who cannot join

Presence of at least one of the epidemic signs: return from an overseas trip 14 days prior to the onset of symptoms; having close contact in the last 14 days with a person under observation for COVID-19 who has subsequently become ill; having close contact within the past 14 days with a person who has a laboratory-confirmed diagnosis of COVID-19;
Positive result of laboratory testing for SARS-CoV-2 RNA using nucleic acid amplification techniques or antigen SARS-CoV-2 antigen using an immunochromatographic assay at the time of screening;
Severe general intoxication syndrome (severe agitation with seizure syndrome and loss of consciousness against a background of hyperthermia);
Hemorrhagic syndrome (nasal bleeding, blood in sputum, vomit and stool, hemorrhagic rash), disseminated intravascular coagulation syndrome (DIC) or Hasser syndrome with the formation of acute renal failure;
Diffuse cyanosis or pallor;
Symptoms of pneumonia and possible acute respiratory distress syndrome (ARDS): cough with frothy sputum with blood, shortened pulmonary sound on percussion, a large number of different-caliber moist rales and abundant crepitation on auscultation, a sharp drop in blood pressure (BP), deafness of heart tones and arrhythmia;

Show all 26Show fewer

Phenomena of respiratory distress combined with any of the following symptoms: grunting breathing, blowing of the wings of the nose when breathing, nodding movements (head movements synchronized with breathing); BPM in a child aged 6-11 months > 50 per minute, child over 1 year old > 40 per minute; lower chest retraction when breathing; blood oxygen saturation (SpO2) < 92% when breathing room air;
Moderate acute respiratory infections (fever ≥ 38.5 °C) with exacerbation of comorbidities;
Presence of any of the following symptoms: inability to drink/breastfeed; drowsiness or unconsciousness; respiratory rate less than 30 per minute or apnea; heart failure phenomena; severe dehydration;
Febrile seizures, including a history of seizures; known intolerance to the active ingredient or excipient of the study drug or placebo components, paracetamol;
12. Lactose intolerance, lactase deficiency or glucose-galactose malabsorption. 13. Taking antibiotics, antivirals, or immunomodulatory drugs within < 48 h prior to the study and/or plans to use these groups of drugs (other than the study drug) during the study; 14. Use of systemic, inhaled, or nasal glucocorticosteroids within 30 days prior to the study and/or plans to use glucocorticosteroids (except topical cutaneous agents) during the study; 15. Failure to withdraw for the duration of the study other medications that may affect the outcome of this study, such as antiviral medications, or medications that are incompatible with the study therapy (see "prohibited concomitant therapies"); 16. Patient's participation in any other clinical trial within 90 days prior to inclusion in the study; 17. Any cardiovascular, renal, hepatic, gastrointestinal (GI), endocrine, or nervous system disease, severe decompensated chronic or acute disease, or any other condition/disease that, in the opinion of the investigating physician, would make it unsafe for the patient to participate in the study; 18. Having any vaccinations administered to the patient within 14 days prior to inclusion in the study; 19. Diabetes mellitus; 20. Clinical suspicion of pneumonia or other bacterial infections (including sinusitis, otitis media, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibacterial drugs; 21. Patients who have had surgery within 30 days prior to the Screening Visit and patients who are scheduled to have surgery, including diagnostic procedures, or a hospital stay during the study; 22. Suspicion of hemophagocytic syndrome; 23. Increased seizure activity in the history; 24. The presence of cancer, HIV infection, tuberculosis, including in the anamnesis; 25. Suspected low compliance of the parent/adopter with the child's treatment and recording of required parameters in the Patient Diary, or inability to perform these procedures and comply with restrictions according to the study protocol (e.g., due to mental illness).
Withdrawal Criteria:
Identification of a probable or confirmed case COVID-19;
Signs of complications of viral infection, including signs of secondary bacterial infection;
The investigating physician decides that the patient must be excluded for the patient's own benefit;
Withdrawal of informed consent by the parent or adoptive parent;
Individual intolerance to the study drug;
Development of NS requiring withdrawal of study drug/placebo;
Erroneous inclusion (for example, the patient was included in violation of the inclusion/inclusion criteria of the protocol);
Patient receives/needs additional treatment that may affect study outcome or patient safety (see "prohibited concomitant therapies");
Persistence of nasal congestion longer than 10 days, worsening of condition after the first week of illness, facial pain;
Patient's development of the conditions described in the criteria for exclusion;
Development of hemorrhagic syndrome (including DIC): nosebleed, hemorrhagic rash on the face, neck, chest, and upper extremities, hemorrhages into the mucous membrane of the mouth and nose, the back of the throat, conjunctivae, blood in vomit, hemoptysis, etc.);
A pronounced intoxication syndrome with the development of encephalic or meningoencephalic reactions (delirium, hallucinations, seizures, confusion or loss of consciousness, vomiting);
Hemophagocytic syndrome;
Other conditions or events that, in the opinion of the investigating physician, require exclusion of the patient from the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Russia8 sites

Federal Research and Clinical Center of Physical and Chemical Medicine of the Federal Medical and Biological Agency
Odintsovo, Moscow Oblast, 1430010
City Pediatric Outpatient Clinic number 5
Perm, 614066
Professors' Clinic LLC.
Perm, 614070
St. Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44"
Saint Petersburg, 191144
City Polyclinic No. 45 of Nevsky District
Saint Petersburg, 193312
PiterKlinika LLC
Saint Petersburg, 196158
Uromed LLC
Smolensk, 214031
Bashkir State Medical University
Ufa, 450008

Other trials in Russia

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children Aged 6 Months to 2 Years With Influenza and Other Acute Respiratory Viral Infections Against Standard Therapy

Conditions: Influenza, Human, Acute Respiratory Infection, Common Cold
Being tested: Ingavirin®, syrup, 30 mg/5 ml, 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®, syrup, 30 mg/5 mlDrug
A dose will be based on the body weight; Ingavirin® will be administered once a day on top of standard therapy.
PlaceboDrug
Placebo will be administered once a day on top of standard therapy.

Study groups in NCT05269290
Study group	Role	What they receive
Ingavirin®, syrup, 30 mg/5 ml	Experimental	Ingavirin®, syrup, 30 mg/5 ml will be administered on top of standard therapy Receives: Drug: Ingavirin®, syrup, 30 mg/5 ml
Placebo	Placebo comparator	Placebo will be administered 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.

Time of symptoms/events resolution
Time, in hours, from the first administration of the drug until all of the following symptoms/events have resolved (if each symptom/event has been achieved for at least 24 hours): Fever; Cough and/or runny nose/nasal congestion; Child's return to normal daytime activity and normal nighttime sleep (as assessed by the parent/adopter).
Measured: From Day 1 up to Day 13-14 (visit 4)

Secondary outcomes (14)

Time to fever relief
Number of hours elapsed from the first administration of the medication to the time of persistent normalization of the temperature, i.e., the moment when the body temperature is < 37.5 °C during the day without the use of antipyretic medication
Measured: From Day 1 up to Day 13-14 (visit 4)
Time to cough relief
Number of hours from the first dose to the time the coughing cough has gone away, i.e. the parent/adoptive parent rates the symptom as 0-1 during the day and records this in the patient's diary
Measured: From Day 1 up to Day 13-14 (visit 4)
Time to cough/nasal congestion relief
Number of hours from first medication administration to cough/congestion cessation, i.e., when parent/adopter rates severity of this symptom during the day at 0-1 point and records this in patient diary
Measured: From Day 1 up to Day 13-14 (visit 4)
Frequency of complications of acute viral infection and influenza
Acute otitis media, viral and bacterial pneumonia, exacerbation of chronic conditions such as bronchial asthma and urinary tract infections), toxemia [septic-like syndrome], acute stenotic laryngotracheitis
Measured: From Day 1 up to Day 13-14 (visit 4)
Frequency of patients with PCR-confirmed viral infection
PCR-confirmed acute respiratory infections/flu by visits 1, 2, 3
Measured: Day 1, Day 3-4 (visit 2), Day 6-7 (visit 3)
Need for paracetamol or ibuprofen
Daily dose on study days 1-7
Measured: Days 1-7
Safety - Number of adverse events (AEs)
Total number of AEs stratified by severity and frequency
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Adverse reactions
Frequency of adverse reactions
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Serious adverse events (SAEs)
Frequency of serious adverse events (SAEs) associated with study drug/placebo use
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Percentage of patients with AEs
Percentage of patients with at least one AE
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Percentage of patients who interrupted treatment
Percentage of patients who interrupted treatment due to AE
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Frequency of complications
Frequency of complications
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Frequency of worsening
Frequency of worsening of the disease course
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Frequency of hospitalization
Frequency of need for hospitalization
Measured: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202115 Jul 2022

First posted7 Mar 2022
Study start23 Sep 2021
Primary completion29 Apr 2022
Study completion15 Jul 2022

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05269290
Sponsor's protocol ID: ING-03-04-2020
Status last verified: Jul 2023
First submitted: 28 Jan 2022
Last updated: 27 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children Aged 6 Months to 2 Years With Influenza and Other Acute Respiratory Viral Infections Against Standard Therapy
ClinicalTrials.gov ID: NCT05269290
Acronym / sponsor ID: ING-03-04-2020
Conditions: Influenza, Human, Acute Respiratory Infection, Common Cold
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Valenta Pharm JSCIndustry (pharma, biotech, devices)
Study start: 23 Sep 2021 (actual)
Primary completion: 29 Apr 2022 (actual)
Study completion: 15 Jul 2022 (actual)
First posted: 7 Mar 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ingavirin®, syrup, 30 mg/5 ml	Experimental	Drug: Ingavirin®, syrup, 30 mg/5 mlIngavirin®, syrup, 30 mg/5 ml will be administered on top of standard therapy
Placebo	Placebo comparator	Drug: PlaceboPlacebo will be administered on top of standard therapy

Who may qualify

Ages: 6 months to 2 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Patient's parent/adoptive parent's informed consent form voluntarily signed by the patient's parent/adoptive parent;
Boys and girls aged 6 months - 2 years 11 months 14 days, inclusive, with the following clinical signs of acute respiratory infections/flu: body temperature above 38.0 °C but not higher than 39.0 °C (without taking antipyretics within the last 8 h) at the time of screening/randomization; at least one of the respiratory manifestations of acute respiratory infection/influenza (cough, runny nose/ stuffy nose) of at least 2 points on a 4-point scale; decrease in the child's daytime activity and change in nighttime sleep, as compared with the state before the illness;
There were no indications for hospitalization at the time of inclusion in the study;
Duration of illness from manifestation of symptoms to inclusion in the study not more than 48 hours.

Key exclusion criteria (26 listed)

Presence of at least one of the epidemic signs: return from an overseas trip 14 days prior to the onset of symptoms; having close contact in the last 14 days with a person under observation for COVID-19 who has subsequently become ill; having close contact within the past 14 days with a person who has a laboratory-confirmed diagnosis of COVID-19;
Positive result of laboratory testing for SARS-CoV-2 RNA using nucleic acid amplification techniques or antigen SARS-CoV-2 antigen using an immunochromatographic assay at the time of screening;
Severe general intoxication syndrome (severe agitation with seizure syndrome and loss of consciousness against a background of hyperthermia);
Hemorrhagic syndrome (nasal bleeding, blood in sputum, vomit and stool, hemorrhagic rash), disseminated intravascular coagulation syndrome (DIC) or Hasser syndrome with the formation of acute renal failure;
Diffuse cyanosis or pallor;

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®, syrup, 30 mg/5 mlA dose will be based on the body weight; Ingavirin® will be administered once a day on top of standard therapy.	Drug	Ingavirin®, syrup, 30 mg/5 ml
PlaceboPlacebo will be administered once a day on top of standard therapy.	Drug	Placebo

Primary outcome

Time of symptoms/events resolution
Time frame: From Day 1 up to Day 13-14 (visit 4)
Time, in hours, from the first administration of the drug until all of the following symptoms/events have resolved (if each symptom/event has been achieved for at least 24 hours): Fever; Cough and/or runny nose/nasal congestion; Child's return to normal daytime activity and normal nighttime sleep (as assessed by the parent/adopter).

14 secondary outcomes

Time to fever relief
Time frame: From Day 1 up to Day 13-14 (visit 4)
Time to cough relief
Time frame: From Day 1 up to Day 13-14 (visit 4)
Time to cough/nasal congestion relief
Time frame: From Day 1 up to Day 13-14 (visit 4)
Frequency of complications of acute viral infection and influenza
Time frame: From Day 1 up to Day 13-14 (visit 4)
Frequency of patients with PCR-confirmed viral infection
Time frame: Day 1, Day 3-4 (visit 2), Day 6-7 (visit 3)
Need for paracetamol or ibuprofen
Time frame: Days 1-7
Safety - Number of adverse events (AEs)
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Adverse reactions
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Serious adverse events (SAEs)
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Percentage of patients with AEs
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Percentage of patients who interrupted treatment
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Frequency of complications
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Frequency of worsening
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study
Safety - Frequency of hospitalization
Time frame: From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ingavirin®, syrup, 30 mg/5 ml in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 8 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 4 inclusion and 26 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: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of symptoms/events resolution (time frame: From Day 1 up to Day 13-14 (visit 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05269290.

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 27 Jul 2023.