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

• Sponsor: Materia Medica Holding (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03039621
• Collaborator: (none)
• Enrollment: 287
• Locations: 13
• Arms: 2
• Actual Duration (Months): 27.1
• Patients Per Site: 22.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Viral Infections	Drug: Ergoferon; Drug: Placebo	Phase 4

Detailed 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".

Study Design

• Study Type: Interventional
• Actual Enrollment: 287 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 7, 2016
• Actual Primary Completion Date: Jan 9, 2019
• Actual Study Completion Date: Jan 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ergoferon Tablet for oral use, 1 tablet per intake (outside a meal/feeding). 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 (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days.	Drug: Ergoferon; For oral use.
Placebo Comparator: Placebo Placebo using Ergoferon scheme.	Drug: Placebo; For oral use.

Outcome Measures

Primary Outcome Measures

1. Time to Alleviation of All ARVI Symptoms. [14 days of observation.]

   Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С 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.

Secondary Outcome Measures

1. Time to Normalization of Body Temperature. [14 days of observation.]

   Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).

2. Time to Alleviation of Flu-like Nonspecific Symptoms. [14 days of observation.]

   Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.

3. Time to Alleviation of Respiratory Symptoms. [14 days of observation.]

   Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.

4. Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6. [On days 2-6 of the observation period.]

   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.

5. ARVI Severity. [On days 2-6 of the observation period.]

   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: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.

6. Percentage of Recovered Patients. [On days 2-6 of the observation period.]

   Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С 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).

7. Rates of Antipyretics Use Per Patient. [On days 1- 5 of the treatment period.]

   Based on patient diary data. The number of intakes of prescribed antipyretics.

8. Percentage of Patients With Worsening of Illness. [14 days of observation peiod.]

   Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. The first 24 hours after ARVI onset.

2. Seasonal raise in ARVI incidence.

3. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kazakh Medical Continuing Education University	Almaty		Kazakhstan	050057
2	Astana Medical University	Astana		Kazakhstan	010000
3	Karaganda State Medical University	Karaganda		Kazakhstan	100000
4	Municipal autonomous institution "Children's City Clinical Hospital №11"	Ekaterinburg		Russian Federation	620028
5	Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation	Kazan'		Russian Federation	420012
6	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	117997
7	Limited Liability Company "Diagnostics and Vaccines"	Moscow		Russian Federation	129515
8	St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"	Moscow		Russian Federation	192071
9	Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"	Perm'		Russian Federation	614066
10	State Budgetary Institution of Healthcare of the Samara Region "Samara City Children's Clinical Hospital named after N.N. Willow New	Samara		Russian Federation	443079
11	Volgograd State Medical University	Volgograd		Russian Federation	400131
12	Yaroslavl State Medical University/Children's Clinic # 5	Yaroslavl'		Russian Federation	150000
13	Yaroslavl State Medical University/Clinical Hospital # 8	Yaroslavl'		Russian Federation	150000

Sponsors and Collaborators

• Materia Medica Holding

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 3, 2015

More Information

Publications

None provided.

• Responsible Party: Materia Medica Holding
• ClinicalTrials.gov Identifier: NCT03039621
• Other Study ID Numbers: MMH-ER-009
• First Posted: Feb 1, 2017
• Last Update Posted: Aug 27, 2021
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Infections; Communicable Diseases; Virus Diseases

Study Results

Participant Flow

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Period Title: Overall Study
STARTED	143	144
COMPLETED	131	128
NOT COMPLETED	12	16

Baseline Characteristics

Arm/Group Title	Ergoferon	Placebo	Total
Arm/Group Description	Ergoferon: Tablet for oral use, 1 tablet per intake (outside a meal/feeding). 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 (total 8 tablets). From day 2, one tablet is taken every 8 hours.	Placebo: Placebo using Ergoferon scheme.	Total of all reporting groups
Overall Participants	143	144	287
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.3 (1.7)	3.4 (1.7)	3.4 (1.7)
Sex: Female, Male (Count of Participants)
Female	73 51%	73 50.7%	146 50.9%
Male	67 46.9%	69 47.9%	136 47.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Kazakhstan	26 18.2%	25 17.4%	51 17.8%
Russia	117 81.8%	119 82.6%	236 82.2%

Outcome Measures

1. Primary Outcome

Title	Time to Alleviation of All ARVI Symptoms.
Description	Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С 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.
Time Frame	14 days of observation.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Mean (95% Confidence Interval) [days]	4.5	5.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments	a priori threshold for statistical significance equals 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Time to Normalization of Body Temperature.
Description	Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).
Time Frame	14 days of observation.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Mean (95% Confidence Interval) [days]	2.8	3.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Time to Alleviation of Flu-like Nonspecific Symptoms.
Description	Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.
Time Frame	14 days of observation.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Mean (95% Confidence Interval) [days]	4.0	4.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Time to Alleviation of Respiratory Symptoms.
Description	Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.
Time Frame	14 days of observation.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Mean (95% Confidence Interval) [days]	4.3	5.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.
Description	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.
Time Frame	On days 2-6 of the observation period.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Day 2	12.0	13.1
Day 3	8.7	9.7
Day 4	6.2	7.1
Day 5	3.9	5.1
Day 6	2.5	3.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0201
	Comments	The p-value associated with "treatment" factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	ARVI Severity.
Description	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: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.
Time Frame	On days 2-6 of the observation period.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Mean (95% Confidence Interval) [score on a scale*day]	39.6	44.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Percentage of Recovered Patients.
Description	Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С 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).
Time Frame	On days 2-6 of the observation period.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Day 2	20 14%	20 13.9%
Day 3	37 25.9%	35 24.3%
Day 4	72 50.3%	61 42.4%
Day 5	102 71.3%	91 63.2%
Day 6	119 83.2%	98 68.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0025
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	Breslow-Day test
	Comments

8. Secondary Outcome

Title	Rates of Antipyretics Use Per Patient.
Description	Based on patient diary data. The number of intakes of prescribed antipyretics.
Time Frame	On days 1- 5 of the treatment period.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Day 1	1.5	1.6
Day 2	1.0	1.2
Day 3	0.4	0.5
Day 4	0.2	0.2
Day 5	0.0	0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0037
	Comments	The p-value associated with "treatment" factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
	Method	Mixed Models Analysis
	Comments

9. Secondary Outcome

Title	Percentage of Patients With Worsening of Illness.
Description	Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).
Time Frame	14 days of observation peiod.

Outcome Measure Data

Analysis Population Description

ITT sample

Arm/Group Title	Ergoferon	Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.	1 tablet 3 times a day. Placebo: Inside, orally.
Measure Participants	140	142
Count of Participants [Participants]	1 0.7%	19 13.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ergoferon, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	Adverse/Serious adverse events were registered during 14 days (during the treatment and follow-up periods).
Adverse Event Reporting Description	Adverse/Serious adverse events were registered in patients of the Safety population (n=287).
Arm/Group Title	Ergoferon		Placebo
Arm/Group Description	1 tablet 3 times a day. Ergoferon: Inside, orally.		1 tablet 3 times a day. Placebo: Inside, orally.
All Cause Mortality
	Ergoferon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/143 (7%)		27/144 (18.8%)
Serious Adverse Events
	Ergoferon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/143 (0%)		0/144 (0%)
Other (Not Including Serious) Adverse Events
	Ergoferon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/143 (7%)		27/144 (18.8%)
Blood and lymphatic system disorders
Lymphadenitis	0/143 (0%)	0	1/144 (0.7%)	1
Cardiac disorders
Tachycardia	0/143 (0%)	0	1/144 (0.7%)	1
Eye disorders
Eyelid oedema	0/143 (0%)	0	1/144 (0.7%)	1
Gastrointestinal disorders
Diarrhoea	2/143 (1.4%)	2	1/144 (0.7%)	2
Vomiting	1/143 (0.7%)	1	1/144 (0.7%)	1
Teething	0/143 (0%)	0	1/144 (0.7%)	1
Abdominal pain	1/143 (0.7%)	1	0/144 (0%)	0
General disorders
Hyperthermia	0/143 (0%)	0	1/144 (0.7%)	1
Condition worsened	1/143 (0.7%)	1	3/144 (2.1%)	3
Infections and infestations
Adenoiditis	1/143 (0.7%)	1	8/144 (5.6%)	8
Bronchitis	0/143 (0%)	0	4/144 (2.8%)	4
Gastroenteritis	1/143 (0.7%)	1	0/144 (0%)	0
Tracheitis	1/143 (0.7%)	1	0/144 (0%)	0
Otitis media acute	0/143 (0%)	0	2/144 (1.4%)	2
Otitis media acute	1/143 (0.7%)	1	2/144 (1.4%)	2
Rhinitis	1/143 (0.7%)	1	0/144 (0%)	0
Adenoviral upper respiratory infection	0/143 (0%)	0	1/144 (0.7%)	1
Gastroenterocolitis	0/143 (0%)	0	1/144 (0.7%)	1
Oral herpes	0/143 (0%)	0	1/144 (0.7%)	1
Infectious mononucleosis	1/143 (0.7%)	1	0/144 (0%)	0
Pharyngotonsillitis	0/143 (0%)	0	2/144 (1.4%)	2
Injury, poisoning and procedural complications
Procedural vomiting	0/143 (0%)	0	1/144 (0.7%)	1
Musculoskeletal and connective tissue disorders
Myalgia	0/143 (0%)	0	1/144 (0.7%)	1
Muscle twitching	1/143 (0.7%)	1	0/144 (0%)	0
Torticollis	0/143 (0%)	0	1/144 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	0/143 (0%)	0	1/144 (0.7%)	1
Cough	0/143 (0%)	0	2/144 (1.4%)	2
Skin and subcutaneous tissue disorders
Dermatitis atopic	0/143 (0%)	0	1/144 (0.7%)	1
Urticaria	1/143 (0.7%)	1	0/144 (0%)	0
Exfoliative rash	1/143 (0.7%)	1	0/144 (0%)	0
Rash	0/143 (0%)	0	1/144 (0.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.