Trial Outcomes & Findings for Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults (NCT NCT01765920)
NCT ID: NCT01765920
Last Updated: 2021-01-05
Results Overview
Primary outcome measure is based on the indicators of tympanic thermometry recorded by the patient in the diary during the period of treatment and observation. Thermometry is performed twice a day (morning and evening). The criterion of Duration of Fever is the time from enrollment to the first return to the afebrile state or the normalization of tympanic temperature (tympanic temperature ≤37.0 degree Celsius \[°C\]).
COMPLETED
PHASE3
342 participants
1-7 days
2021-01-05
Participant Flow
Participant milestones
| Measure |
Ergoferon (5 ml 3 Times a Day)
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
173
|
|
Overall Study
COMPLETED
|
167
|
167
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Ergoferon (5 ml 3 Times a Day)
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Overall Study
Incorrect inclusion ineligible patient
|
2
|
5
|
|
Overall Study
Patient code disclosure
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=169 Participants
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=173 Participants
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=169 Participants
|
0 Participants
n=173 Participants
|
0 Participants
n=342 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
169 Participants
n=169 Participants
|
173 Participants
n=173 Participants
|
342 Participants
n=342 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=169 Participants
|
0 Participants
n=173 Participants
|
0 Participants
n=342 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 10.6 • n=169 Participants
|
35.1 years
STANDARD_DEVIATION 10.9 • n=173 Participants
|
35.7 years
STANDARD_DEVIATION 10.8 • n=342 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=169 Participants
|
115 Participants
n=173 Participants
|
213 Participants
n=342 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=169 Participants
|
58 Participants
n=173 Participants
|
129 Participants
n=342 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
169 participants
n=169 Participants
|
173 participants
n=173 Participants
|
342 participants
n=342 Participants
|
PRIMARY outcome
Timeframe: 1-7 daysPopulation: One patient in the placebo group did not have enough source data for primary outcome analysis.
Primary outcome measure is based on the indicators of tympanic thermometry recorded by the patient in the diary during the period of treatment and observation. Thermometry is performed twice a day (morning and evening). The criterion of Duration of Fever is the time from enrollment to the first return to the afebrile state or the normalization of tympanic temperature (tympanic temperature ≤37.0 degree Celsius \[°C\]).
Outcome measures
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=167 Participants
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=166 Participants
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Average Duration of Fever.
|
3.1 days
Standard Deviation 1.2
|
3.6 days
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Day 1, 3, and 7.Population: One patient in the placebo group and one patient in Ergoferon group did not have enough source data for secondary outcome analysis.
Acute URTI symptoms severity is based on the Common Cold Questionnaire (CCQ) and assessed using the "Area under the curve" (AUC) for the total scores on days 1, 3, and 7 of treatment according to the physical examination by the doctor. AUC is calculated by trapezoidal rule. CCQ includes 3 General Symptoms (fevers, chills, muscle pains), 3 Nasal Symptoms (Watery eyes, Runny nose, Sneezing), 1 Throat Symptom (Sore throat), and 2 Chest Symptoms (Cough, Chest pain). Every CCQ symptom is estimated according to the 4-point scoring: none = 0, mild = 1, moderate = 2, severe = 3. Total CCQ scores equal the sum of all scores. The minimum value is 0, and the maximum value is 162. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=166 Participants
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=166 Participants
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Dynamics of Acute Upper Respiratory Tract Infections (URTI) Symptoms Severity According to the Physical Examination by the Doctor.
|
25.7 score on a scale*day
Standard Deviation 12.0
|
28.5 score on a scale*day
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Days 1 to 8.Population: One patient in the placebo group did not have enough source data for secondary outcome analysis.
Dynamics of symptoms severity according to the WURSS-21 is assessed using the Area under the curve (AUC) for the score for 8 days of the treatment. AUC is calculated by trapezoidal rule. WURSS-21 consists of 21 items (2 questions and 2 domains. Symptoms domain consists of 10 items: Runny nose, Plugged nose, Sneezing, Sore throat, Scratchy throat, Cough, Hoarseness, Head congestion, Chest congestion, Feeling tired. Ability domain consists of 9 items: Think clearly, Sleep well, Breathe easily, Walk, climb stairs, exercise, Accomplish daily activities, Work outside the home, Work inside the home, Interact with others, Live your personal life. The first 20 items are scored according to the 8-point scale (from 0 to 7). The last item is scored according to the 7-point scale: (from 0 to 6). Total WURSS-21 AUC min score=0, max=1169. Symptoms domain min score=0, max=560. Ability domain min score=0, max=504. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=167 Participants
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=166 Participants
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Dynamics of Acute URTI Symptoms Severity According to the Daily Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) Assessment of the Patient (Including the Total WURSS-21 Score, "Symptoms" Domain Score, and "Ability" Domain Score).
Total WURSS-21 score
|
201.6 score on a scale*day
Standard Deviation 106.1
|
236.2 score on a scale*day
Standard Deviation 127.9
|
|
Dynamics of Acute URTI Symptoms Severity According to the Daily Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) Assessment of the Patient (Including the Total WURSS-21 Score, "Symptoms" Domain Score, and "Ability" Domain Score).
"Symptoms" domain score
|
85.2 score on a scale*day
Standard Deviation 47.6
|
100.4 score on a scale*day
Standard Deviation 54.0
|
|
Dynamics of Acute URTI Symptoms Severity According to the Daily Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) Assessment of the Patient (Including the Total WURSS-21 Score, "Symptoms" Domain Score, and "Ability" Domain Score).
"Ability" domain score
|
84.3 score on a scale*day
Standard Deviation 58.9
|
102.0 score on a scale*day
Standard Deviation 72.0
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, and 5.Population: One patient in the placebo group did not have enough source data for secondary outcome analysis.
Based on the patient's diary. The outcome is calculated according to the number of patients who were administered the antipyretics due to the fever.
Outcome measures
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=167 Participants
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=166 Participants
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Percentage of Patients Who Used Antipyretics.
Day 1
|
61 Participants
|
72 Participants
|
|
Percentage of Patients Who Used Antipyretics.
Day 2
|
27 Participants
|
34 Participants
|
|
Percentage of Patients Who Used Antipyretics.
Day 3
|
7 Participants
|
10 Participants
|
|
Percentage of Patients Who Used Antipyretics.
Day 4
|
3 Participants
|
4 Participants
|
|
Percentage of Patients Who Used Antipyretics.
Day 5
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4.,5, 6, and 7.The number of patients with the appearance of the lower respiratory tract symptoms, development of complications requiring antibiotics or hospitalization.
Outcome measures
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=167 Participants
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=167 Participants
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Percentage of Patients Who Have a Worsening of Disease.
|
3 Participants
|
2 Participants
|
Adverse Events
Ergoferon (5 ml 3 Times a Day)
Placebo (5 ml 3 Times a Day)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ergoferon (5 ml 3 Times a Day)
n=169 participants at risk
Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing.
Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily.
Ergoferon: 5 ml 3 times a day
|
Placebo (5 ml 3 Times a Day)
n=173 participants at risk
Oral use. Placebo using Ergoferon scheme.
Placebo: 5 ml 3 times a day
|
|---|---|---|
|
Gastrointestinal disorders
Acute anal fissure
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.00%
0/173 • 8 days (during the study).
|
|
Blood and lymphatic system disorders
Increased lymphocytes
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.00%
0/173 • 8 days (during the study).
|
|
Blood and lymphatic system disorders
Decreased level of segmented neutrophils
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.00%
0/173 • 8 days (during the study).
|
|
Blood and lymphatic system disorders
Increased levels of transaminases (ALT, AST)
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
|
Renal and urinary disorders
A large amount of salts in the urine (urates)
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.00%
0/173 • 8 days (during the study).
|
|
Renal and urinary disorders
Increased red blood cells in the urine
|
0.00%
0/169 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
|
Renal and urinary disorders
The presence of mucus in the urine
|
0.00%
0/169 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
|
Infections and infestations
Sinusitis
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.00%
0/173 • 8 days (during the study).
|
|
Respiratory, thoracic and mediastinal disorders
Acute bilateral rhinosinusitis
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.00%
0/173 • 8 days (during the study).
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
0.59%
1/169 • Number of events 1 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
|
Infections and infestations
Community-acquired pneumonia of the lower lobe of the right lung
|
0.00%
0/169 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/169 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
|
Skin and subcutaneous tissue disorders
Facial hyperemia
|
0.00%
0/169 • 8 days (during the study).
|
0.58%
1/173 • Number of events 1 • 8 days (during the study).
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
Materia Medica Holding
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place