Common ColdPhase 3ACCORDNCT02644018
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
A Phase 3 study testing Imidazolyl ethanamide pentandioic acid in people with Common Cold and Influenza, run by Valenta Pharm JSC at 13 sites in Russia.
Trial summary
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Common Cold, Influenza
- What is being tested?
- Imidazolyl ethanamide pentandioic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 13 sitesRussia
- Study dates
- Jan 2016to May 2016
- 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 3 to 6 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 3-6.
- Patients with moderate course of influenza or other acute respiratory viral infections.
- 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.
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- Established diagnosis J06.9, J10, J11, in accordance with ICD-10.
- 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 14 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).
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- 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
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
Kazan'
GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
Krasnoyarsk
FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
Moscow
I.M. Sechenov First Moscow State Medical University
Moscow
Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
Moscow
GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
Novosibirsk
Children's city outpatients clinic № 5
Perm
Children's city outpatients clinic № 4
Rostov-on-Don
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
Rostov-on-Don
FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
Saint Petersburg
FGBOU VPO "Mordov State University n.a. N.P. Ogarev"
Saransk
GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
Tomsk
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl
About this study
Official title: Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.
- Conditions
- Common Cold, Influenza
- Being tested
- Imidazolyl ethanamide pentandioic acid, placebo
- Keywords
- Ingavirin, Common Cold, Influenza, Acute Respiratory Viral Infections, pediatric clinical trial, Imidazolyl ethanamide pentandioic acid
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imidazolyl ethanamide pentandioic acidDrug
Also called Ingavirin
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ingavirin | Experimental | Ingavirin (Imidazolyl ethanamide pentandioic acid), capsules 30 mg daily for 5 days. The contents of one capsule of Ingavirin, capsules 30 mg should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal. Receives: Drug: Imidazolyl ethanamide pentandioic acid |
| Placebo | Placebo comparator | Placebo, capsules daily for 5 days. The contents of one capsule of placebo should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature
Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.
Measured: 5 days
Secondary outcomes (11)
Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
Measured: 5 days
Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Measured: Within 6 days from the start of treatment
The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment
Measured: 5 days
Time to normalization of body temperature from the start of treatment, measured in hours
Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start
Measured: 5 days
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Measured: 5 days
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Measured: 5 days
The area under the "temperature-time" curve by the 5th day after the start of treatment
Measured: 5 days
The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment
Measured: 14 days
The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment
Measured: 14 days
Time to onset of complications of influenza and other ARVI from the start of treatment
Measured: 14 days
Assessment of adverse events (AEs) and serious adverse events (SAEs)
Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of -
- Portion of patients who developed one or more SAE during the study
- Portion of patients who developed one or more AE during the study
- Portion of patients who developed one or more severe AE during the study
- Portion of patients who developed one or more AE with definite relationship to the investigational product/ placebo during the study
- Portion of patients who developed one or more AE with definite or probable relationship to the investigational product/ placebo during the study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies 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
- 190 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 JSCYuriy V. Lobzin, MD, PhD, Principal investigator, Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644018
- Sponsor's protocol ID
- ING-03-02-2015
- Acronym
- ACCORD
- Status last verified
- Feb 2016
- First submitted
- 22 Dec 2015
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy
- ClinicalTrials.gov ID
- NCT02644018
- Acronym / sponsor ID
- ACCORD / ING-03-02-2015
- Conditions
- Common Cold, Influenza
- Keywords
- Ingavirin, Common Cold, Influenza, Acute Respiratory Viral Infections, pediatric clinical trial, Imidazolyl ethanamide pentandioic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Collaborators
- Atlant Clinical Ltd.
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- 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 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 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: Imidazolyl ethanamide pentandioic acidIngavirin (Imidazolyl ethanamide pentandioic acid), capsules 30 mg daily for 5 days. The contents of one capsule of Ingavirin, capsules 30 mg should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal. |
| Placebo | Placebo comparator | Drug: placeboPlacebo, capsules daily for 5 days. The contents of one capsule of placebo should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study.
- Male and female patients aged 3-6.
- Patients with moderate course of influenza or other acute respiratory viral infections.
- 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:
- Established diagnosis J06.9, J10, J11, in accordance with ICD-10.
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 14 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 |
|---|---|---|
| Imidazolyl ethanamide pentandioic acidAlso: Ingavirin | Drug | Ingavirin |
| placebo | Drug | Placebo |
Primary outcome
Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature
Time frame: 5 days
Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.
11 secondary outcomes
Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
Time frame: 5 days
Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time frame: Within 6 days from the start of treatment
The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment
Time frame: 5 days
Time to normalization of body temperature from the start of treatment, measured in hours
Time frame: 5 days
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time frame: 5 days
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time frame: 5 days
The area under the "temperature-time" curve by the 5th day after the start of treatment
Time frame: 5 days
The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment
Time frame: 14 days
The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment
Time frame: 14 days
Time to onset of complications of influenza and other ARVI from the start of treatment
Time frame: 14 days
Assessment of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 14 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 9 Jun 2016.
- 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
Yuriy V. Lobzin, MD, PhD principal investigator
Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation
13 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 Imidazolyl ethanamide pentandioic acid in people with Common Cold and Influenza, run by Valenta Pharm JSC at 13 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 9 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 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature (time frame: 5 days). 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 9 Jun 2016.