Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

Acute Respiratory Viral Infections Clinical Trial

Official title:

International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039621
• Other study ID #: MMH-ER-009
• Status: Completed
• Phase: Phase 4
• Start date: October 7, 2016
• Est. completion date: January 9, 2019

Study information

• Verified date: May 2019
• Source: Materia Medica Holding
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.

Description:

Study design: international, multicenter double-blind placebo-controlled randomized clinical study in parallel groups.

The study will enroll patients of either gender aged from 6 months to 6 years old with clinical manifestations of ARVI within the first days after the onset of the disease. Patients will be included evenly (1:1 ratio) in accordance with the age group: 6 months - 3 years 11 months 29 days; 4 years - 6 years 11 months 29 days. Signed information sheet for parents/adopters (inform consent form) will be obtained from all participant's parents/ adopters prior to the screening procedures. Medical history, thermometry, patient examination by the doctor, assesment of ARVI symptoms severity and nasopharyngeal swabswill be performed at screening visit (Day 1).

If the inclusion criteria are met and exclusion criteria are absent, the patient is included in the study.

Nasopharyngeal swabs will be analyzed by real-time reverse transcription polymerase chain reaction (RT-PCR) to identify the most common respiratory viruses, including (1) Influenza A virus; (2) Influenza B virus; (3) Influenza A (H1N1)pdm; (4) Human metapneumovirus; (5) Human respiratory syncytial virus; (6) Human rhinovirus; (7) Human adenovirus; (8) Human bocavirus; (9) Human parainfluenza virus 1; (10) Human parainfluenza virus 2; (11) Human parainfluenza virus 3; (12) Human parainfluenza virus 4; (13) Human coronavirus OC43; (14) Human coronavirus 229E; (15) Human coronavirus HKU1; (16) Human coronavirus NL63.

The patients are randomized into one of two groups: the 1st group patients will take Ergoferon according to the dosage regimen for 5 days; the 2nd group patients will take Placebo according to the dosage regimen of Ergoferon for 5 days. Patient's parents/ adoptive parents are provided with diares, where daily in the morning and at hight they record oral temperature (measured by a digital thermometer provided by Sponsor), symptoms of ARVI (according to the 4-points scale), administered drug and concomitant therapy. The doctors instruct parents/ adoptive parents how to fill in the diaries; the first scores of ARVI symptoms severity and oral temperature are made by doctors together with the parents/adoptive parents.

Patients are observed up for 14 days (screening and randomization - up to 1 day, therapy for 5 days, follow-up from 6 to 10 days; delayed telephone "visit" - on day 14).

During the observation period, two visits are planned (at home or at the medical center) on day 3 (Visit 2) and day 6 (Visit 3). If patients still have any symptoms of ARVI/ complications of ARVI, then an additional (unscheduled) Visit 4 is provided on Day 10 of the observation (at the medical center). During Visits 2, 3 (4), doctors carry out an physical examination, record dynamics of ARVI symptoms and concomitant therapy, check patient's diaries, which parents/adoptive parents return back at Visit 3 or 4. At Visit 3 (after 5 days of therapy) compliance with the treatment is additionally assessed. A "telephone visit" (Visit 5, Day 14 ± 1) is carried out to interview parents about the patient's condition, presence/ absence of complications, and possible use of antibiotics.

During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Therapy".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

Inclusion Criteria:

1. Patients of both genders aged from 6 months to 6 years old.

2. ARVI based on medical examination: oral temperature of at least 38.0°C at examination + total symptom severity =5.

3. The first 24 hours after ARVI onset.

4. Seasonal raise in ARVI incidence.

5. Availability of signed information sheet for parents/adopters(Informed Consent Form) for participation in the clinical trial.

Exclusion Criteria:

1. Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media, urinary tract infection, etc.) requiring a prescription of antibacterial product from the first day of the disease.

2. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).

3. Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.

4. Medical history of primary and secondary immunodeficiency; oncologic conditions.

5. Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck and salivary and thyroid glands, etc.) which affect the patient's ability to participate in the clinical study.

6. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.

7. Allergy/hypersensitivity to any components of the drug product used in the therapy.

8. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.

9. Patients whose parents/adoptive parents will not fulfil the requirements during the study or follow the order of administration of the studied drug products from the investigator's point of view.

10. Participation in other clinical trials within 3 months prior to the enrollment in this study.

11. The patient's parent/adoptive parent is a study specialist at the centre and is directly involved in the study or is an immediate family member of the investigator. Spouses parents, children or siblings, regardless of whether they are siblings or adopted are considered immediate family members.

12. The patient's parent/adoptive parent works at OOO "NPF "MATERIA MEDICA HOLDING", i.e. they are employees of the Company, temporary employees on a contract basis or appointed official responsible for conduction of the study or their immediate family members.

Related Conditions & MeSH terms

• Acute Respiratory Viral Infections
• Communicable Diseases
• Infection
• Virus Diseases

Intervention

Drug:
• Ergoferon
For oral use.
• Placebo
For oral use.

Locations

Country	Name	City	State
Kazakhstan	Kazakh Medical Continuing Education University	Almaty
Kazakhstan	Astana Medical University	Astana
Kazakhstan	Karaganda State Medical University	Karaganda
Russian Federation	Municipal autonomous institution "Children's City Clinical Hospital ?11"	Ekaterinburg
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation	Kazan'
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation	Moscow
Russian Federation	Limited Liability Company "Diagnostics and Vaccines"	Moscow
Russian Federation	St. Petersburg State Budgetary Health Care Institution "?ity Polyclinic ?44"	Moscow
Russian Federation	Municipal Health Care Institution "City Child Health Clinical Polyclinic ?5"	Perm'
Russian Federation	State Budgetary Institution of Healthcare of the Samara Region "Samara City Children's Clinical Hospital named after N.N. Willow New	Samara
Russian Federation	Volgograd State Medical University	Volgograd
Russian Federation	Yaroslavl State Medical University/Children's Clinic # 5	Yaroslavl'
Russian Federation	Yaroslavl State Medical University/Clinical Hospital # 8	Yaroslavl'

Sponsors (1)

Lead Sponsor	Collaborator
Materia Medica Holding

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Alleviation of All ARVI Symptoms.	Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature =37.5? for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with =3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.	14 days of observation.
Secondary	Time to Normalization of Body Temperature.	Based on patient diary data. Oral temperature =37.5? for 24 hours (without subsequent increase within the observation period).	14 days of observation.
Secondary	Time to Alleviation of Flu-like Nonspecific Symptoms.	Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.	14 days of observation.
Secondary	Time to Alleviation of Respiratory Symptoms.	Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.	14 days of observation.
Secondary	Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.	Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.	On days 2-6 of the observation period.
Secondary	ARVI Severity.	Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: =37.5? = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; =38.90? = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.	On days 2-6 of the observation period.
Secondary	Percentage of Recovered Patients.	Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature =37.5? for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with =3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).	On days 2-6 of the observation period.
Secondary	Rates of Antipyretics Use Per Patient.	Based on patient diary data. The number of intakes of prescribed antipyretics.	On days 1- 5 of the treatment period.
Secondary	Percentage of Patients With Worsening of Illness.	Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).	14 days of observation peiod.