Acute Upper Respiratory InfectionsPhase 3NCT03162458

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

A Phase 3 study testing Anaferon for children (liquid dosage form) in people with Acute Upper Respiratory Infections, run by Materia Medica Holding at 7 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 1 month to 3 years
Conditions the study is for: Acute Upper Respiratory Infections
What is being tested?: Anaferon for children (liquid dosage form)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 7 sitesRussia
Study dates: 22 Jan 2015to 29 Apr 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 1 month to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Russia7 sites

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

Other trials in Russia

About this study

Official title: Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

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: Acute Upper Respiratory Infections
Being tested: Anaferon for children (liquid dosage form), Placebo (liquid dosage form)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anaferon for children (liquid dosage form)Drug
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.
Placebo (liquid dosage form)Drug
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.

Study groups in NCT03162458
Study group	Role	What they receive
Anaferon for children	Experimental	Not described Receives: Drug: Anaferon for children (liquid dosage form)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo (liquid dosage form)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: On days 1-5 of observation

Secondary outcomes (8)

Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
based on patient diary data
Measured: On Days 2-5 of the treatment
Average Duration of Fever (i.e. Body Temperature >37.3°С)
based on patient diary data
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From the time of randomization up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201529 Apr 2015

First posted22 May 2017
Study start22 Jan 2015
Primary completion29 Apr 2015
Study completion29 Apr 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 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: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03162458
Sponsor's protocol ID: MMH-AD-006
Status last verified: Nov 2018
First submitted: 19 May 2017
Last updated: 28 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
ClinicalTrials.gov ID: NCT03162458
Acronym / sponsor ID: MMH-AD-006
Conditions: Acute Upper Respiratory Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Materia Medica HoldingIndustry (pharma, biotech, devices)
Study start: 22 Jan 2015 (actual)
Primary completion: 29 Apr 2015 (actual)
Study completion: 29 Apr 2015 (actual)
First posted: 22 May 2017 (actual)
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.

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.

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

Who may qualify

Ages: 1 month to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (17 listed)

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
Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.

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
Anaferon 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.	Drug	Anaferon for children
Placebo (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.	Drug	Placebo

Primary outcome

Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
Time frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days
based on patient diary data
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).
Time frame: On days 1-5 of observation
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.

8 secondary outcomes

Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (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)
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)
Time frame: On Days 2-5 of the treatment
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
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
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)
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)
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 and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anaferon for Children	71	71
Placebo	71	71

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

Time frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days. Mean (Standard Deviation). Unit: hours

Measure	Anaferon for Children n = 71	Placebo n = 71
Value	87.7 (31.5)	103.3 (19.4)

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

Population analysed: Intention to treat set

Primary outcome: 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).

Time frame: On days 1-5 of observation. Mean (Standard Deviation). Unit: AUC score*day

Measure	Anaferon for Children n = 71	Placebo n = 71
Value	25.6 (17.2)	33.6 (17.7)

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

Population analysed: Intention to treat set

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse/Serious adverse events were registered from Day 1 to Day 14. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anaferon for Children	0 of 71 (0%)	7 of 71 (9.9%)	Not reported
Placebo	0 of 71 (0%)	4 of 71 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 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.

7 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 Anaferon for children (liquid dosage form) in people with Acute Upper Respiratory Infections, run by Materia Medica Holding at 7 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 6 inclusion and 17 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 28 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 7 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?

Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data) (time frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03162458.

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 28 Nov 2018.