Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections (NCT NCT03707912)
NCT ID: NCT03707912
Last Updated: 2020-09-02
Results Overview
Based on a patient diary. ARVI is clinically diagnosed and/or Real-time reverse transcription polymerase chain reaction (PCR) confirmed. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome).
COMPLETED
PHASE4
204 participants
On days 1-7 of the observation period.
2020-09-02
Participant Flow
Participant milestones
| Measure |
Anaferon
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
100
|
|
Overall Study
COMPLETED
|
103
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Anaferon
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Overall Study
Violation of inclusion criteria
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Anaferon
n=103 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=103 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=203 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=103 Participants
|
100 Participants
n=100 Participants
|
203 Participants
n=203 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=103 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=203 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 13.4 • n=103 Participants
|
37.8 years
STANDARD_DEVIATION 11.9 • n=100 Participants
|
38.5 years
STANDARD_DEVIATION 12.7 • n=203 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=103 Participants
|
73 Participants
n=100 Participants
|
139 Participants
n=203 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=103 Participants
|
27 Participants
n=100 Participants
|
64 Participants
n=203 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
103 participants
n=103 Participants
|
100 participants
n=100 Participants
|
203 participants
n=203 Participants
|
PRIMARY outcome
Timeframe: On days 1-7 of the observation period.Based on a patient diary. ARVI is clinically diagnosed and/or Real-time reverse transcription polymerase chain reaction (PCR) confirmed. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome).
Outcome measures
| Measure |
Anaferon
n=103 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms.
|
4.1 days
Standard Deviation 1.6
|
4.5 days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: On days 1-6 of the observation period.ARVI severity is assessed using the "Area under the curve" (AUC) for the Total Symptom (TS) score for 6 days of the treatment and observation. TS score is calculated every day according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome). AUC is calculated between 6 points (by TS for every 6 days of the treatment and observation). AUC is calculated using integration with given limits (TS score). The minimum value for the AUC is "0" and the maximum value is "252" units (day\*score). The higher score means a worse outcome (ARVI severity).
Outcome measures
| Measure |
Anaferon
n=103 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
ARVI Severity.
|
104.6 day*score
Standard Deviation 43.5
|
114.3 day*score
Standard Deviation 45.7
|
SECONDARY outcome
Timeframe: On day 2, 3, 4, 5, and 6.Based on patient diary data. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 30 (higher scores mean a worse outcome).
Outcome measures
| Measure |
Anaferon
n=103 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
Day 2
|
0 Participants
|
0 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
Day 3
|
11 Participants
|
6 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
Day 4
|
39 Participants
|
25 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
Day 5
|
57 Participants
|
43 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
Day 6
|
76 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: On days 2-6 of the observation period.Population: From all patients with ARVI only 79 have ARVI (PCR-confirmed), including 41 patient in Anaferon group and 38 patient in Placebo groupe.
Based on patient diary data. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome).
Outcome measures
| Measure |
Anaferon
n=41 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=38 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Time to Resolution of ARVI (PCR-confirmed) Symptoms.
|
3.6 days
Standard Deviation 1.5
|
4.6 days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: On day 2, 3, 4, 5, and 6.Population: From all patients with ARVI only 79 have ARVI (PCR-confirmed), including 41 patient in Anaferon group and 38 patient in Placebo group.
Based on patient diary data. ARVI is PCR confirmed. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 30 (higher scores mean a worse outcome).
Outcome measures
| Measure |
Anaferon
n=41 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=38 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
Day 2
|
0 Participants
|
0 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
Day 3
|
7 Participants
|
4 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
Day 4
|
22 Participants
|
10 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
Day 5
|
29 Participants
|
14 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
Day 6
|
35 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: On day 1, 2, and 3.Based on patient diary data. Dosing frequency is calculated as the number of antipyretic doses per 1 patient in a day.
Outcome measures
| Measure |
Anaferon
n=103 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Dosing Frequency of Antipyretics if Indicated.
Day 1
|
0.4 doses
Standard Deviation 0.6
|
0.4 doses
Standard Deviation 0.6
|
|
Dosing Frequency of Antipyretics if Indicated.
Day 2
|
0.2 doses
Standard Deviation 0.4
|
0.2 doses
Standard Deviation 0.4
|
|
Dosing Frequency of Antipyretics if Indicated.
Day 3
|
0.1 doses
Standard Deviation 0.3
|
0.1 doses
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: On days 4-7 of the observation period.Based on medical records. This Outcome Measure is calculated as the number of patients who were administered antibiotics for the treatment of secondary bacterial complications.
Outcome measures
| Measure |
Anaferon
n=103 Participants
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 Participants
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
The Percentage of Patients Requiring Administration of Antibiotics.
|
4 Participants
|
5 Participants
|
Adverse Events
Anaferon
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anaferon
n=104 participants at risk
1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day.
Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.
Anaferon: Oral administration.
|
Placebo
n=100 participants at risk
Placebo using Anaferon regimen until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
General disorders
Intoxication Syndrome Intensification
|
0.00%
0/104 • 7 days
|
1.0%
1/100 • Number of events 1 • 7 days
|
|
Infections and infestations
Community-acquired pneumonia
|
0.00%
0/104 • 7 days
|
1.0%
1/100 • Number of events 1 • 7 days
|
|
Infections and infestations
Acute tracheobronchitis
|
0.00%
0/104 • 7 days
|
1.0%
1/100 • Number of events 1 • 7 days
|
|
Infections and infestations
Community-acquired bacterial infection with bacterial bronchitis
|
0.96%
1/104 • Number of events 1 • 7 days
|
0.00%
0/100 • 7 days
|
|
Infections and infestations
Community-acquired bacterial infection with purulent rhinitis
|
0.96%
1/104 • Number of events 1 • 7 days
|
0.00%
0/100 • 7 days
|
|
Infections and infestations
Acute tracheitis
|
0.00%
0/104 • 7 days
|
1.0%
1/100 • Number of events 1 • 7 days
|
|
Nervous system disorders
Headache
|
0.96%
1/104 • Number of events 1 • 7 days
|
0.00%
0/100 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
2.9%
3/104 • Number of events 3 • 7 days
|
2.0%
2/100 • Number of events 2 • 7 days
|
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