Acute Upper Respiratory Tract InfectionsPhase 3NCT01843842
Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
A Phase 3 study testing Ergoferon in people with Acute Upper Respiratory Tract Infections, run by Materia Medica Holding at 11 sites in Russia.
Trial summary
The purpose of this study is: to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children; to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infections
- What is being tested?
- Ergoferon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 11 sitesRussia
- Study dates
- Apr 2013to Mar 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both sexes aged over 3 years and under 18 years.
- Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.
- The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
- Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
- Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.
Who cannot join
- Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
- Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
- Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
- Medical history of sarcoidosis.
- Oncological diseases.
- Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
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- Medical history of polyvalent allergy.
- Allergy/ intolerance to any of the components of medications used in the treatment.
- Impaired glucose tolerance, diabetes mellitus.
- Hereditary fructose intolerance (as the study drug contains maltitol).
- Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
- Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
- Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
- Mental disorders of patient or of patient's parents/adopters.
- Patient's parents/ adopters, who from investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
- Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
- Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
- Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
Moscow, 119992
State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation
Novosibirsk, 630091
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, 614066
St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region"
Saint Peterburg, 193312
State Budgetary Health Care Institution "Сity Child Health Polyclinic №44"
Saint Petersburg, 191144
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Saint Petersburg, 192212
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
Saint Petersburg, 194100
Limited Liability Company "Alliance Biomedical-Russian group"
Saint Petersburg, 194356
State Health Care Institution "Child Health City Hospital №22"
Saint Petersburg, 196650
State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health
Yaroslavl, 150000
Municipal Institution "Child Health City Hospital №11"
Yekaterinburg, 620028
About this study
Official title: Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
The purpose of this study is:
- to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children;
- to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
Read the detailed description
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).
- Conditions
- Acute Upper Respiratory Tract Infections
- Being tested
- Ergoferon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgoferonDrug
Safety and Efficiency of liquid dosage form
PlaceboDrug
Safety and Efficiency of liquid dosage form
| Study group | Role | What they receive |
|---|---|---|
| Ergoferon (5 ml 3 times a day) | Experimental | Not described Receives: Drug: Ergoferon |
| Placebo (5 ml 3 times a day) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Based on the data mentioned in a patient's diary
Measured: On day 2, 3 and 4 of observation
Secondary outcomes (7)
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Measured: baseline and days 2, 3, 4 and 5 of observation
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Axillary temperature (morning and evening) decline to or below 37.0 ºС
Measured: On day 2, 3, 4, 5 of observation
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom.
The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).
The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С).
Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
Measured: on Days 2, 3, 4, 5 of Observation
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).
The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Measured: baseline and days 2, 3, 4 and 5 of observation
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom.
The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).
The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С).
Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Measured: On days 1-6 of observation
Number of Intakes of Antipyretics if Indicated
Based on data mentioned in a patient's diary
Measured: On day 1, 2, 3, 4 and 5 of the treatment
Percentage of Patients With Exacerbation of the Disease Course
The development of disease complications requiring antibiotics administration or hospitalization
Measured: On days 1-6 of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843842
- Sponsor's protocol ID
- MMH-ER-007
- Status last verified
- Nov 2018
- First submitted
- 26 Apr 2013
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
- ClinicalTrials.gov ID
- NCT01843842
- Acronym / sponsor ID
- MMH-ER-007
- Conditions
- Acute Upper Respiratory Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 3 Aug 2018
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 assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children;
- to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
Detailed description
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).
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 |
|---|---|---|
| Ergoferon (5 ml 3 times a day) | Experimental | Drug: Ergoferon |
| Placebo (5 ml 3 times a day) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients of both sexes aged over 3 years and under 18 years.
- Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.
- The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
- Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
- Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.
Key exclusion criteria (18 listed)
- Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
- Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
- Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
- Medical history of sarcoidosis.
- Oncological diseases.
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 |
|---|---|---|
| ErgoferonSafety and Efficiency of liquid dosage form | Drug | Ergoferon (5 ml 3 times a day) |
| PlaceboSafety and Efficiency of liquid dosage form | Drug | Placebo (5 ml 3 times a day) |
Primary outcome
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Time frame: On day 2, 3 and 4 of observation
Based on the data mentioned in a patient's diary
7 secondary outcomes
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Time frame: baseline and days 2, 3, 4 and 5 of observation
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Time frame: On day 2, 3, 4, 5 of observation
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Time frame: on Days 2, 3, 4, 5 of Observation
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Time frame: baseline and days 2, 3, 4 and 5 of observation
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Time frame: On days 1-6 of observation
Number of Intakes of Antipyretics if Indicated
Time frame: On day 1, 2, 3, 4 and 5 of the treatment
Percentage of Patients With Exacerbation of the Disease Course
Time frame: On days 1-6 of observation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 Ergoferon in people with Acute Upper Respiratory Tract Infections, run by Materia Medica Holding 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 5 inclusion and 18 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 29 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) (time frame: On day 2, 3 and 4 of observation). 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 29 Nov 2018.