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CompletedNCT02072174Updated Jul 12, 2019Results posted

Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children

A Phase 4 interventional study of Anaferon for Children in Influenza and Acute Respiratory Viral Infections, sponsored by Materia Medica Holding. Completed at 27 sites in 3 countries. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Materia Medica Holding · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
569
Allocation
Randomized
Ages
3 Years to 12 Years
Sex
All
01

Study summary

The purpose of this study is:

  • To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children
Read the detailed description

The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever

≥ 38.0°С having an appointment with a doctor within the first day after the illness onset.

Тhe physician will collect medical history information, perform an objective examination, record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic influenza test. If the swab is positive, the doctor shall obtain swab specimens from the nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A and/or B virus. If the swab is negative for influenza the doctor shall collect a nasopharyngeal swab for a subsequent PCR test for other respiratory viruses.

If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the patient will be enrolled in the trial and randomized into one of the two groups: group 1 patients will take Anaferon for children following a 5-day regimen; group 2 patients will receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient will receive a diary where they should record the child's axillary temperature data in the morning and evening, and score the severity of symptoms.

The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5 days, follow-up - 1 day; late-scheduled phone "visit" - day 14).

At Visits 2-4, the physician will document objective examination data; obtain nasopharyngeal swabs from subjects with positive influenza tests for subsequent RT-PCR to determine the viral load and its reduction in the course of treatment; monitor the prescribed and concomitant therapy, and check the patient's diary data. The phone "visit" will be made to elicit information from the parents regarding the patient's general health, presence/absence of secondary bacterial/viral complications, and use of antibacterial drugs.

Interim statistical analysis is stipulated by the study protocol. Interim analysis will be performed using the data obtained from the examination and treatment of the protocol-defined number of patients who completed the study. Based on the expected effect, the minimum required Particular Per Protocol (pPP) sample size will be 254 patients (127 subjects in each group - Anaferon for children and Placebo).

02

Conditions studied

  • Influenza and Acute Respiratory Viral Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 569 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Materia Medica Holding is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients of both sexes aged 3-12 years inclusively.
  2. Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥ 38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2 and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).
  3. The first 24 hours from the beginning of manifestations of influenza/ARVI.
  4. The possibility to start therapy within 24 hours from the first symptoms of ARVI.
  5. Availability of a patient information sheet (Informed Consent form) for parents/adoptive parents for participation in the study signed by one of the parents/adoptive parents.

Exclusion criteria

Exclusion Criteria:

  1. Suspected pneumonia, bacterial infection or severe disease requiring antibacterial products (including sulfanilamides) starting from the first day of the disease.
  2. Clinical symptoms of severe influenza/ARVI requiring hospitalization.
  3. Suspected initial manifestations of the diseases having the symptoms similar to the ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of systemic connective tissue diseases, oncohematological and other diseases).
  4. Medical history of primary and secondary immunodeficiencies: а) lymphoid system immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome; polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital asplenia; immune complex pathological syndrome associated with infectious, autoimmune and allergic diseases.
  5. Medical history of sarcoidosis.
  6. Oncology.
  7. Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
  8. Medical history of polyvalent allergy.
  9. Allergy/intolerance to any of the components of medications used in the treatment.
  10. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
  11. Intake of medicines listed in the section "Prohibited concomitant therapy" within 1 month prior to the inclusion in the study.
  12. Drug addiction, alcohol consumption at more than 2 alcohol units per day by the subject's parents/adoptive parents.
  13. Mental diseases of the subject, parents/adoptive parents.
  14. Subjects whose parents/adoptive parents, according to the investigator's point of view, will not follow the observation requirements during the study or study product dosing regimen.
  15. Participation in other clinical studies within 3 months prior to the inclusion in the study.
  16. Parent/adoptive parent of the subject is related to the investigator team of medical facility directly involved in the study or is a close relative of the investigator. Close relatives include spouse, parents, children or brothers (sisters) regardless of whether they are biological or adoptive ones.
  17. Parent/adoptive parent of the subject is working in OOO "NPF "Materia Medica Holding", i.e. is the company official, temporary contract worker or an appointed official responsible for the study or their close relatives.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
569 participants (actual)

Study arms

  • Experimental
    Anaferon for Children

    On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily.

    Drug: Anaferon for Children

  • Placebo comparator
    Placebo

    On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily.

    Drug: Anaferon for Children

Interventions

  • DrugAnaferon for Children

    Anaferon for children: For oral use.

    Also known as: Anaferon for Children in tablets

06

What researchers measure

Primary outcomes

  1. Average Illness Duration

    Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.

    Time frame: From the time of randomization until the time of recovery/improvement (days 1-14)

Secondary outcomes

  1. Percentage of Patients With Recovery/Improvement in Health

    Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).

    Time frame: on days 2, 3, 4 and 5 of the treatment

  2. Changes in Body Temperature

    Changes in Body Temperature Based on Patient Diary Data

    Time frame: baseline and days 2, 3, 4 and 5 of observation treatment

  3. Percentage of Patients With Normal Body Temperature (≤37.0ºС)

    Based on the patient diary data. Axillary temperature (morning and evening) decline to or below 37.0 ºС.

    Time frame: on days 2, 3, 4 and 5 of observation treatment

  4. Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.

    Total Symptom Score is based on the severity of each Influenza / Acute Respiratory Viral Infection symptom. Total Symptom Score includes 13 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms. The severity of non-specific and nasal/throat/chest symptom is scored on a symptom severity scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). Minimum score=0; maximum score=39. The severity of symptoms is recorded by the doctors on the case record form on days 3, 5 and by parents/adopter on a diary card twice a day on days 2-6.

    Time frame: on days 2-6 of observation treatment

  5. Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment

    Total Symptom Score is based on the severity of each disease symptom. The TSS includes 13 symptoms: body temperature/fever, non-specific 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). Minimum score=0; maximum score=39. The area under the curve 1 = on days 1, 3, 5 and 7 on the results of doctor's examination The area under the curve 2 = based on days 1-7 on the patient diary data

    Time frame: on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)

  6. Number of Intakes of Antipyretics

    Number of Intakes of Antipyretics based on patient diary data

    Time frame: on days 1-5 of therapy

  7. Change in Viral Load During the Treatment and Follow-up Periods

    Viral load is evaluated in subjects with positive influenza A and B tests. Virus load \[log10 copies influenza А/В RNA per 1 mL\] in nasal and pharyngeal swabs is determined using real-time PCR on days 1, 3, 5 and 7.

    Time frame: on days 1, 3, 5, 7 of observation treatment

  8. Percentage of Patients With Exacerbation of the Disease Course

    The development of disease complications requiring antibiotics drugs or hospitalization

    Time frame: 14 days of observation treatment

07

Results

Posted Jul 12, 2019

Participant flow

Participant flow — Overall Study
MilestoneAnaferon for ChildrenPlacebo
Started290279
Completed258240
Not completed3239
Withdrew: Did not meet in-/exclusion criteria1415
Withdrew: Protocol violation1623
Withdrew: Physician decision01
Withdrew: Non-compliance with protocol requirement20

Outcome measures

PrimaryAverage Illness Duration

Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.

Time frame:
From the time of randomization until the time of recovery/improvement (days 1-14)
Reported as:
Mean · days
Average Illness Duration
daysAnaferon for ChildrenPlacebo
Average Illness Duration4.6 ± 1.44.9 ± 1.3
Statistical analysis
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0242
SecondaryPercentage of Patients With Recovery/Improvement in Health

Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).

Time frame:
on days 2, 3, 4 and 5 of the treatment
Reported as:
Count of participants · Participants
Percentage of Patients With Recovery/Improvement in Health
ParticipantsAnaferon for ChildrenPlacebo
Day 2 (patient diary data)11
Day 3 (patient diary data)2511
Day 4 (patient diary data)6140
Day 5 (patient diary data)10784
Day 3 (physician's examination)3116
Day 5 (physician's examination)11690
Statistical analysis
  • Anaferon for Children vs Placebo · Cochran-Mantel-Haenszel · p = 0.0026
  • Anaferon for Children vs Placebo · Cochran-Mantel-Haenszel · p = 0.0127
SecondaryChanges in Body Temperature

Changes in Body Temperature Based on Patient Diary Data

Time frame:
baseline and days 2, 3, 4 and 5 of observation treatment
Reported as:
Mean · °C
Changes in Body Temperature
°CAnaferon for ChildrenPlacebo
Day 138.5 ± 0.438.5 ± 0.4
Day 238.0 ± 0.838.2 ± 0.8
Day 337.4 ± 0.837.5 ± 0.8
Day 437.0 ± 0.637.1 ± 0.7
Day 536.8 ± 0.436.9 ± 0.4
Statistical analysis
  • Anaferon for Children vs Placebo · Mixed Models Analysis · p = 0.0394 (The p-value associated with "treatment" factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate. Treatment\*visit interaction p-value is 0.3220.)
  • Anaferon for Children vs Placebo · Mixed Models Analysis · p = 0.3220 (The p-value associated with "treatment\*visit" interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate.)
SecondaryPercentage of Patients With Normal Body Temperature (≤37.0ºС)

Based on the patient diary data. Axillary temperature (morning and evening) decline to or below 37.0 ºС.

Time frame:
on days 2, 3, 4 and 5 of observation treatment
Reported as:
Count of participants · Participants
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
ParticipantsAnaferon for ChildrenPlacebo
Day 2 (patient diary data)3123
Day 3 (patient diary data)10476
Day 4 (patient diary data)167139
Day 5 (patient diary data)219196
Statistical analysis
  • Anaferon for Children vs Placebo · Cochran-Mantel-Haenszel · p = 0.0043
SecondarySeverity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.

Total Symptom Score is based on the severity of each Influenza / Acute Respiratory Viral Infection symptom. Total Symptom Score includes 13 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms. The severity of non-specific and nasal/throat/chest symptom is scored on a symptom severity scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). Minimum score=0; maximum score=39. The severity of symptoms is recorded by the doctors on the case record form on days 3, 5 and by parents/adopter on a diary card twice a day on days 2-6.

Time frame:
on days 2-6 of observation treatment
Reported as:
Mean · score on a scale
Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.
score on a scaleAnaferon for ChildrenPlacebo
Day 2 (patient diary data)10.0 ± 5.311.0 ± 5.1
Day 3 (patient diary data)7.0 ± 4.88.1 ± 4.8
Day 4 (patient diary data)5.0 ± 3.85.5 ± 3.8
Day 5 (patient diary data)3.3 ± 2.93.8 ± 3.1
Day 3 (physician's examination)7.0 ± 4.68.1 ± 4.8
Day 5 (physician's examination)3.5 ± 3.03.9 ± 3.0
Statistical analysis
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0104 (p-value not adjusted for multiple comparisons)
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0041 (p-value not adjusted for multiple comparisons)
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0484 (p-value not adjusted for multiple comparisons)
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0603 (p-value not adjusted for multiple comparisons)
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0056 (p-value not adjusted for multiple comparisons)
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0994 (p-value not adjusted for multiple comparisons)
SecondaryAssessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment

Total Symptom Score is based on the severity of each disease symptom. The TSS includes 13 symptoms: body temperature/fever, non-specific 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). Minimum score=0; maximum score=39. The area under the curve 1 = on days 1, 3, 5 and 7 on the results of doctor's examination The area under the curve 2 = based on days 1-7 on the patient diary data

Time frame:
on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)
Reported as:
Mean · score*day
Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment
score*dayAnaferon for ChildrenPlacebo
Days 1-7 (patient diary data)34.4 ± 18.838.2 ± 18.5
Days 1, 3, 5 and 7 (physician's examination)17.6 ± 8.919.3 ± 8.9
Statistical analysis
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0084
  • Anaferon for Children vs Placebo · Kruskal-Wallis · p = 0.0233
SecondaryNumber of Intakes of Antipyretics

Number of Intakes of Antipyretics based on patient diary data

Time frame:
on days 1-5 of therapy
Reported as:
Mean · Number of intakes
Number of Intakes of Antipyretics
Number of intakesAnaferon for ChildrenPlacebo
Day 11.2 ± 0.91.3 ± 1.0
Day 20.7 ± 1.00.9 ± 1.1
Day 30.3 ± 0.60.4 ± 0.8
Day 40.1 ± 0.40.1 ± 0.5
Day 50.0 ± 0.20.1 ± 0.4
Statistical analysis
  • Anaferon for Children vs Placebo · Mixed Models Analysis · p = 0.0721
SecondaryChange in Viral Load During the Treatment and Follow-up Periods

Viral load is evaluated in subjects with positive influenza A and B tests. Virus load \[log10 copies influenza А/В RNA per 1 mL\] in nasal and pharyngeal swabs is determined using real-time PCR on days 1, 3, 5 and 7.

Time frame:
on days 1, 3, 5, 7 of observation treatment
Reported as:
Mean · log10 copies influenza А/В RNA per 1 mL
Change in Viral Load During the Treatment and Follow-up Periods
log10 copies influenza А/В RNA per 1 mLAnaferon for ChildrenPlacebo
Day 15.7 ± 1.15.6 ± 1.3
Day 34.1 ± 2.24.8 ± 1.3
Day 53.1 ± 2.34.4 ± 1.3
Day 72.1 ± 2.44.0 ± 1.5
Statistical analysis
  • Anaferon for Children vs Placebo · Mixed Models Analysis · p = 0.0001
SecondaryPercentage of Patients With Exacerbation of the Disease Course

The development of disease complications requiring antibiotics drugs or hospitalization

Time frame:
14 days of observation treatment
Reported as:
Count of participants · Participants
Percentage of Patients With Exacerbation of the Disease Course
ParticipantsAnaferon for ChildrenPlacebo
Percentage of Patients With Exacerbation of the Disease Course711
Statistical analysis
  • Anaferon for Children vs Placebo · Fisher Exact · p = 0.3383

Adverse events

Collected over Adverse/Serious adverse events were registered during 14 days (during the treatment and follow-up periods ).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Anaferon for Children0/290 (0%)1/290 (0.3%)26/290 (9%)
Placebo0/279 (0%)1/279 (0.4%)30/279 (10.8%)
Most frequent serious events
Most frequent serious events
EventAnaferon for ChildrenPlacebo
InfluenzaInfections and infestations1/2901/279
Most frequent other events
Showing 10 of 33
Most frequent other events
EventAnaferon for ChildrenPlacebo
Otitis media acuteInfections and infestations4/2905/279
BronchitisInfections and infestations3/2904/279
ConjunctivitisInfections and infestations1/2903/279
Abdominal painGastrointestinal disorders3/2902/279
EpistaxisRespiratory, thoracic and mediastinal disorders3/2900/279
RhinitisInfections and infestations3/2901/279
Bacterial infectionInfections and infestations0/2902/279
InfectionInfections and infestations1/2902/279
NasopharyngitisInfections and infestations0/2902/279
NauseaGastrointestinal disorders0/2902/279

Baseline characteristics

Age, Continuous
Age, Continuous(years)Anaferon for ChildrenPlaceboTotal
Mean6.8 ± 2.76.7 ± 2.76.7 ± 2.7
Sex: Female, Male
Sex: Female, Male(Participants)Anaferon for ChildrenPlaceboTotal
Female118115233
Male140125265
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Anaferon for ChildrenPlaceboTotal
Count of participants——0
Count of Participants
Count of Participants(Participants)Anaferon for ChildrenPlaceboTotal
Count of participants258240498
08

Study locations

27 sites
  • City Child Health Clinical Polyclinic №13
    Minsk, 220024, Belarus
  • Municipal Health Care Institution "City Child Health Clinical Polyclinic №10"
    Minsk, 220118, Belarus
  • City Child Health Clinical Polyclinic №17
    Minsk, 220131, Belarus
  • Clinic of State Budgetary Institution "Research Institute of nutrition" of the Russian Academy of Medical Sciences
    Moscow, 109240, Russian Federation
  • Russian National Research Medical University named after N.I. Pirogov
    Moscow, 117997, Russian Federation
  • Russian National Research Medical University
    Moscow, 117997, Russian Federation
  • Russian National Research Pirogov Medical University
    Moscow, 117997, Russian Federation
  • State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
    Moscow, 119991, Russian Federation
  • State Budgetary Institution of Health, "Children's City Hospital № 9 named after G.N. Speranskii"
    Moscow, 123317, Russian Federation
  • State Budgetary Educational Institution of Additional Professional Education "Russian Russian Medical Academy of Postgraduate Education" of Ministry of Health of Russian Federation
    Moscow, 123995, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education " Nizhny Novgorod State Medical Academy" of Ministry of Health of Russian Federation
    Nizhnij Novgorod, 603005, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education ''Novosibirsk State Medical University'' of Ministry of Health of Russian Federation
    Novosibirsk, 630091, Russian Federation
  • Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
    Perm, 614066, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University"
    Rostov-na-Donu, 344022, Russian Federation
  • St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
    St. Petersburg, 192212, Russian Federation
  • St. Petersburg State health institution " City Child Health Polyclinic № 45"
    St. Petersburg, 193312, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
    St. Petersburg, 194100, Russian Federation
  • Co.Ltd "Clinic Allergomed"
    St. Petersburg, 196084, Russian Federation
  • State Health Care Institution "Child Health City Hospital №22"
    St. Petersburg, 196650, Russian Federation
  • Limited Liability Company "Alliance Biomedical-Russian group"
    St.Petersburg, 194356, Russian Federation
  • Bashkir State Medical University of Ministry of Health of Russian Federation
    Ufa, 450000, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health of Russian Federation
    Yaroslavl, 150000, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"
    Yaroslavl, 150000, Russian Federation
  • State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy
    Yaroslavl, 150000, Russian Federation
  • Yaroslavl State Medical Academy
    Yaroslavl, 150000, Russian Federation
  • Vinnytsya M.I. Pyrogov National Medical University
    Vinnytsya, 21018, Ukraine
  • Public institution "Zaporizhzhya city multidisciplinary children's hospital №5"
    Zaporozh'ye, 69076, Ukraine
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 1, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02072174
Lead sponsor
Materia Medica Holding
Responsible party
Sponsor
First posted
Feb 26, 2014
Start date
Oct 8, 2014
Primary completion
Apr 16, 2018
Completion
Apr 16, 2018
Results posted
Jul 12, 2019
Last update
Jul 12, 2019

Study contacts

Elena Andrianova, Professor
study director · Materia Medica Holding

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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