Influenza, HumanPhase 3NCT03191097
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.
A Phase 3 study testing Ingavirin in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 11 sites in Russia.
Trial summary
The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Influenza, Human, Acute Respiratory Infection, Viral Infection
- 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
- 310 participants
- Where
- 11 sitesRussia
- Study dates
- Aug 2014to Mar 2015
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study
- Male and female patients aged 7-12
- Patients with moderate course of influenza or other acute respiratory viral infections (AVRI)
- Patients with clinically diagnosed influenza or other ARVI based on the body temperature > 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:
- Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;
- Catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion
- Uncomplicated course of influenza and other ARVI
- Interval between onset of symptoms and enrollment to the study of not more than 36 hours
Who cannot join
- Complicated course of influenza and other acute respiratory viral infections
- Treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 7 days prior to the screening visit
- Severe influenza or other ARVI with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes
- Signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs
- Infectious diseases within the last week prior to enrollment
- "RRI children" (incidence of ARVI within the last 12 months is 6 times or more)
Show all 13Show fewer
- Asthma history
- History of increased seizure activity
- Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis and also make it impossible to conduct a clinical study in the patient).
- Cancer, HIV infection, tuberculosis, including those in history
- Hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of Ingavirin product
- Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose malabsorption, deficiency of glucose-6-phosphate dehydrogenase
- Participation of the patient in any other clinical trial within the last 90 days prior to enrollment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
Kazan', 420012
Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
Krasnoyarsk, 660022
I.M. Sechenov First Moscow State Medical University
Moscow, 119991
Novosibirsk State Medical University
Novosibirsk, 630091
City Pediatric Outpatient Clinic number 5
Perm, 614066
Rostov State Medical University
Rostov-on-Don, 344022
Pediatrics outpatient clinic number 4 of Rostov-na-Donu
Rostov-on-Don, 344065
Ogarev Mordovia State University
Saransk, 430005
Saratov State Medical University named after V. I. Razumovsky
Saratov, 410012
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl, 150000
Pediatrician City Hospital number 11
Yekaterinburg, 62028
About this study
Official title: Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Children 7-12 y.o.
The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.
- Being tested
- Ingavirin, Placebo oral capsule
- Medical subject headings
- Influenza, Human, Virus Diseases, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IngavirinDrug
Also called Imidazolyl ethanamide pentandioic acid
Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.
Placebo oral capsuleDrug
Placebo, capsules daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Ingavirin | Experimental | Not described Receives: Drug: Ingavirin |
| Placebo oral capsule | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of fever
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)
Measured: 7 ± 1 days
Secondary outcomes (2)
Time to resolution of intoxication symptoms
Time from the start of study treatment to resolution of all intoxication symptoms.
Measured: 7 ± 1 days
Time to resolution of catarrhal symptoms
Time from the start of study treatment to resolution of all catarrhal symptoms.
Measured: 7 ± 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startAug 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlant Clinical Ltd.
- Responsible party
- Sponsor
- Investigators
- Ekaterina Zakharova, MD, PhD, Study director, Valenta Pharm JSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191097
- Sponsor's protocol ID
- 4K/2013
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
I.M. Farber, N.A. Geppe, D.V. Reikhart, V.E. Nebolsin, V.S. Arnautov, A.A. Globenko. Therapy for influenza and acute respiratory viral infection in young and middle-aged schoolchildren: Effect of Ingavirin® on intoxication, fever, and catarrhal syndromes. Ros Vestn Perinatol Pediat 2016; 2:115-120. Russian.
N.A. Geppe, E.D. Teplyakova, A.A. Shuldyakov, E.P. Lyapina, O.A. Perminova, G.P. Martynova, I.G. Sitnikov, V.A. Anohin, G.R. Fatkullina, V.V. Romanenko, A.A. Savisko, E.G. Kondyurina, L.A. Balykova. Innovations in pediatrics: the optimal clinical effect In acute respiratory viral infections treatment In children with complex action drug. Pediatry 2016, 2(95), 97-103. Russian.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Children 7-12 y.o.
- ClinicalTrials.gov ID
- NCT03191097
- Acronym / sponsor ID
- 4K/2013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Collaborators
- Atlant Clinical Ltd.
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jun 2017 (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 purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingavirin | Experimental | Drug: Ingavirin |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsule |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study
- Male and female patients aged 7-12
- Patients with moderate course of influenza or other acute respiratory viral infections (AVRI)
- Patients with clinically diagnosed influenza or other ARVI based on the body temperature > 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:
- Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;
Key exclusion criteria (13 listed)
- Complicated course of influenza and other acute respiratory viral infections
- Treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 7 days prior to the screening visit
- Severe influenza or other ARVI with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes
- Signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs
- Infectious diseases within the last week prior to enrollment
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 |
|---|---|---|
| IngavirinAlso: Imidazolyl ethanamide pentandioic acidIngavirin capsules 60 mg once daily, regardless of meal, for 5 days. | Drug | Ingavirin |
| Placebo oral capsulePlacebo, capsules daily for 5 days. | Drug | Placebo oral capsule |
Primary outcome
Time to resolution of fever
Time frame: 7 ± 1 days
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)
2 secondary outcomes
Time to resolution of intoxication symptoms
Time frame: 7 ± 1 days
Time to resolution of catarrhal symptoms
Time frame: 7 ± 1 days
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 19 Jun 2017.
- Results publicationI.M. Farber, N.A. Geppe, D.V. Reikhart, V.E. Nebolsin, V.S. Arnautov, A.A. Globenko. Therapy for influenza and acute respiratory viral infection in young and middle-aged schoolchildren: Effect of Ingavirin® on intoxication, fever, and catarrhal syndromes. Ros Vestn Perinatol Pediat 2016; 2:115-120. Russian.
- Results publicationN.A. Geppe, E.D. Teplyakova, A.A. Shuldyakov, E.P. Lyapina, O.A. Perminova, G.P. Martynova, I.G. Sitnikov, V.A. Anohin, G.R. Fatkullina, V.V. Romanenko, A.A. Savisko, E.G. Kondyurina, L.A. Balykova. Innovations in pediatrics: the optimal clinical effect In acute respiratory viral infections treatment In children with complex action drug. Pediatry 2016, 2(95), 97-103. Russian.
- Individual participant dataSharing planned: No
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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.
Ekaterina Zakharova, MD, PhD study director
Valenta Pharm JSC
11 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 in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 11 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 8 inclusion and 13 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 to resolution of fever (time frame: 7 ± 1 days). 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 NCT03191097, which also lists 2 linked publications.
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 19 Jun 2017.