CompletedNCT03162458Updated Nov 28, 2018Results posted

Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

A Phase 3 interventional study of Anaferon for children (liquid dosage form) and Placebo (liquid dosage form) in Acute Upper Respiratory Infections, sponsored by Materia Medica Holding. Completed at 7 sites in Russian Federation. Open to participants aged 1 Month to 3 Years. Per ClinicalTrials.gov, last updated 2018-11-28.

Sponsored by Materia Medica Holding · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 2 years 3 months after the study started (first participant enrolled Jan 2015, registered May 2017).

Phase: Phase 3
Study type: Interventional
Enrollment: 142
Allocation: Randomized
Ages: 1 Month to 3 Years
Sex: All

Study summary

Purpose of the study:

To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.
To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.

Conditions studied

Acute Upper Respiratory Infections

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In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 142 is above the median of 120 across 4,201 interventional studies indexed under Infections.

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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.

Who can participate

Ages eligible: 1 Month to 3 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients of both sexes aged 1 month to 3 years.
Diagnosis of acute upper respiratory infection based on a doctor's examination of the patient: body temperature at least 37.8°C when visiting a doctor + symptom scores ≥3 (presence of at least 1 general symptom and 1 nasal/ throat/chest symptom).
The first 24 hours from the beginning of manifestations of acute upper respiratory infection.
Acute respiratory viral infections season.
The possibility to start treatment within 24 hours of the onset of acute upper respiratory infection symptoms.
Availability of a patient information sheet (Informed Consent form) signed by the patient's parents/adopters to confirm the child's participation in the clinical trial signed by one parent/adopter of patient.

Exclusion criteria

Exclusion Criteria:

Suspected pneumonia or bacterial infection or the presence of a disease requiring usage of antibacterial drugs starting from day 1 of the illness onset.
Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring hospitalization.
Suspected early manifestations of diseases that have symptoms similar to ARI symptoms (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology).
Documented (prior diagnosis) or suspected disease such as
- primary or secondary immunodeficiency: а) lymphoid immunodeficiency (T-cell and/or B-cell immunity, immunodeficiencies with predominant antibody deficit, b) phagocyte deficits; c) complement factor deficit; d) combined immunodeficiency including AIDS secondary to HIV infection; toxic, autoimmune, infectious, or radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, autoimmune and allergic diseases;
- cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, congenital malformations of the respiratory system, including malformations of upper respiratory tract, and other chronic lung disease;
- malignant neoplasm.
Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
Medical history of polyvalent allergy.
Allergy/ intolerance to any of the components of medications used in the treatment.
Use of medications listed in 'Prohibited concomitant treatments/medications' within 2 weeks before study entry.
Drug use or alcohol use (more than 2 alc. units daily) by the patient's parent(s)/adopter(s).
Mental disorders of patient's parent(s)/adopter(s).
Patients whose parents/adopters, from the 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 studies in the course of 3 months (or 1-2 months for infants under two months of age) prior to the inclusion in the trial.
Patient's parents/adopters are related to the clinical trial site's research staff directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
The patient's parent/adopter works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family).

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 142 participants (actual)

Study arms

Experimental
Anaferon for children
Drug: Anaferon for children (liquid dosage form)
Placebo comparator
Placebo
Drug: Placebo (liquid dosage form)

Interventions

DrugAnaferon for children (liquid dosage form)
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
DrugPlacebo (liquid dosage form)
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.

What researchers measure

Primary outcomes

Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
based on patient diary data
Time frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI 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.
Time frame: On days 1-5 of observation

Secondary outcomes

Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
based on patient diary data
Time frame: On Days 2-5 of the treatment
Average Duration of Fever (i.e. Body Temperature >37.3°С)
based on patient diary data
Time frame: From the time of randomization until the time of normal body temperature, assessed up to 14 days
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
based on patient diary data
Time frame: On Days 2-5 of the treatment
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
based on patient diary data
Time frame: On Days 2-5 of observation
Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Time frame: On Days 1, 3, 6 of the treatment
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Time frame: on Days 1, 3, 6
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
based on patient diary data
Time frame: on Days 1-5 of treatment
Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation
Time frame: From the time of randomization up to 14 days

Results

Posted Aug 3, 2018

Participant flow

Participant flow — Overall Study
Milestone	Anaferon for Children	Placebo
Started	71	71
Completed	71	71
Not completed	0	0

Outcome measures

PrimaryAverage Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)

based on patient diary data

Time frame:: From the time of randomization until the time of recovery/improvement, assessed up to 14 days
Reported as:: Mean · hours

Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
hours	Anaferon for Children	Placebo
Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)	87.7 ± 31.5	103.3 ± 19.4

Statistical analysis

Anaferon for Children vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.007

PrimarySeverity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).

The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI 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.

Time frame:: On days 1-5 of observation
Reported as:: Mean · AUC score*day

Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).
AUC score*day	Anaferon for Children	Placebo
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).	25.6 ± 17.2	33.6 ± 17.7

Statistical analysis

Anaferon for Children vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.0004

SecondaryPercentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)

based on patient diary data

Time frame:: On Days 2-5 of the treatment
Reported as:: Number · percentage of participants

Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
percentage of participants	Anaferon for Children	Placebo
Day 2	9.9	0
Day 3	29.6	4.2
Day 4	39.4	18.3
Day 5	64.8	57.8

Statistical analysis

Anaferon for Children vs Placebo · Log Rank · p = 0.055

SecondaryAverage Duration of Fever (i.e. Body Temperature >37.3°С)

based on patient diary data

Time frame:: From the time of randomization until the time of normal body temperature, assessed up to 14 days
Reported as:: Mean · hours

Average Duration of Fever (i.e. Body Temperature >37.3°С)
hours	Anaferon for Children	Placebo
Average Duration of Fever (i.e. Body Temperature >37.3°С)	47.3 ± 30.3	57.0 ± 31.6

Statistical analysis

Anaferon for Children vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.051

SecondaryMean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)

based on patient diary data

Time frame:: On Days 2-5 of the treatment
Reported as:: Mean · °C

Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
°C	Anaferon for Children	Placebo
Day 2, Morning	37.4 ± 0.7	37.6 ± 0.7
Day 3, Morning	37.0 ± 0.6	37.1 ± 0.5
Day 4, Morning	36.9 ± 0.6	36.9 ± 0.4
Day 5, Morning	36.7 ± 0.5	36.7 ± 0.6
Day 2, Evening	37.4 ± 0.8	37.5 ± 0.8
Day 3, Evening	37.1 ± 0.7	37.1 ± 0.6
Day 4, Evening	36.9 ± 0.6	36.9 ± 0.6
Day 5, Evening	36.7 ± 0.3	36.8 ± 0.5

Statistical analysis

Anaferon for Children vs Placebo · ANOVA · p = 0.19
Anaferon for Children vs Placebo · ANOVA · p = 0.44

SecondaryPercentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation

based on patient diary data

Time frame:: On Days 2-5 of observation
Reported as:: Number · percentage of participants

Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
percentage of participants	Anaferon for Children	Placebo
Day 2	28.2	12.7
Day 3	56.3	43.7
Day 4	73.2	74.7
Day 5	88.7	83.1

Statistical analysis

Anaferon for Children vs Placebo · Log Rank · p = 0.15

SecondaryTotal Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination

The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.

Time frame:: On Days 1, 3, 6 of the treatment
Reported as:: Mean · Score

Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
Score	Anaferon for Children	Placebo
Day 1	11.8 ± 3.9	12.5 ± 4.6
Day 3	6.0 ± 4.7	8.0 ± 4.6
Day 6	1.9 ± 2.7	2.8 ± 4.8

Statistical analysis

Anaferon for Children vs Placebo · ANOVA · p = 0.004

SecondarySeverity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)

The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.

Time frame:: on Days 1, 3, 6
Reported as:: Mean · AUC score*day

Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)
AUC score*day	Anaferon for Children	Placebo
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)	12.6 ± 7.0	16.0 ± 7.6

Statistical analysis

Anaferon for Children vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.001

SecondaryNumber of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)

based on patient diary data

Time frame:: on Days 1-5 of treatment
Reported as:: Mean · Number of intakes

Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
Number of intakes	Anaferon for Children	Placebo
Day 1	0.8 ± 0.9	0.7 ± 0.9
Day 2	0.5 ± 1.1	0.5 ± 0.8
Day 3	0.2 ± 0.7	0.2 ± 0.5
Day 4	0.2 ± 0.7	0.1 ± 0.5
Day 5	0.1 ± 0.3	0.1 ± 0.4

Statistical analysis

Anaferon for Children vs Placebo · ANOVA · p = 0.63

SecondaryPercentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation

Time frame:: From the time of randomization up to 14 days
Reported as:: Number · percentage of participants

Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation
percentage of participants	Anaferon for Children	Placebo
Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation	2.8	4.2

Statistical analysis

Anaferon for Children vs Placebo · Fisher Exact · p = 1.0

Adverse events

Collected over Adverse/Serious adverse events were registered from Day 1 to Day 14. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Anaferon for Children	—	0/71 (0%)	7/71 (9.9%)
Placebo	—	0/71 (0%)	4/71 (5.6%)

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Anaferon for Children	Placebo
RashSkin and subcutaneous tissue disorders	2/71	0/71
Rhinitis purulentRespiratory, thoracic and mediastinal disorders	2/71	0/71
HyperactivityNervous system disorders	1/71	0/71
Herpes LabialisInfections and infestations	1/71	0/71
DiarrheaGastrointestinal disorders	1/71	0/71
Administration related reactionImmune system disorders	1/71	0/71
EustachitisEar and labyrinth disorders	1/71	0/71
Acute bronchitisRespiratory, thoracic and mediastinal disorders	1/71	0/71
Daytime sleepinessNervous system disorders	0/71	1/71
Purulent conjunctivitisEye disorders	0/71	1/71

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Anaferon for Children	Placebo	Total
Mean	1.8 ± 1.0	1.9 ± 1.0	1.9 ± 1.0

Sex: Female, Male
Sex: Female, Male(Participants)	Anaferon for Children	Placebo	Total
Female	36	32	68
Male	35	39	74

Region of Enrollment
Region of Enrollment(Participants)	Anaferon for Children	Placebo	Total
Russia	71	71	142

Study locations

7 sites

LLC Center for Vaccine Prevention "DIAVAKS"
Moscow, 129515, Russian Federation
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, 614066, Russian Federation
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Saint Petersburg, 192212, Russian Federation
St. Petersburg State Health Care Institution "Children's City Polyclinic No. 45 Nevsky District"
Saint Petersburg, 193312, Russian Federation
Alliance Biomedical-Russian Group LLC
Saint Petersburg, 194356, Russian Federation
St. Petersburg State Budgetary Healthcare Institution "Children's City Hospital No. 22"
Saint Petersburg, 196650, Russian Federation
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Yaroslavl, 150000, Russian Federation

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03162458
Lead sponsor: Materia Medica Holding
Responsible party: Sponsor
First posted: May 22, 2017
Start date: Jan 22, 2015
Primary completion: Apr 29, 2015
Completion: Apr 29, 2015
Results posted: Aug 3, 2018
Last update: Nov 28, 2018

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

From the registry’s dates

Study summary

Conditions studied

Browse trials for

In context

Infections

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria