A Phase 4 interventional study of Anaferon and Placebo in Acute Respiratory Viral Infections, sponsored by Materia Medica Holding. Completed at 19 sites in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by Materia Medica Holding · Phase 4, Interventional, and Treatment
Purpose of the study:
Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial.
The study will enroll patients of either gender aged 18-70 years old with clinical manifestations of ARVI within the first day after the onset of the disease. Signed information sheet for patient will be obtained from all participants prior to the screening procedures. Medical history, concomitant medication, thermometry, patient examination by a doctor, assessment of ARVI symptoms severity will be performed at screening visit.
The nasopharyngeal swabs will be performed for Real-time reverse transcription polymerase chain reaction (PCR) assay to confirm viral etiology of ARVI and to verify respiratory viruses prior to the therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1) he/she will be randomized into one of two groups: the 1st group patients will take Anaferon according to the dosage regimen until the end of the study; the 2nd group patients will take Placebo according to Anaferon dosage regimen until the end of the study.
The patients will be provided with a patient diary (paper or electronic) where daily they will record axillary body temperature (using a Geratherm Classic thermometer) and each ARVI symptom severity twice a day (in the morning and in the evening). In addition, antipyretic administration (if applicable) as well as any possible worsening of the patient's condition (if applicable, for safety evaluation/AEs documentation) will also be recorded in a patient diary. An investigator will provide the instructions on filling out the diary and will help the patient to make first records of ARVI symptom severity and body temperature in the diary.
Patients are observed up for 7 days (screening, randomization - 1 day, study therapy - 5 days, follow-up period - 2 days). During treatment and follow-up period two visits are scheduled (at home or at the study site) on days 5 (Visit 2) and day 7 (Visit 3). At Visits 2 and 3, the investigator will carry out physical examination, record dynamics of ARVI symptoms and concomitant therapy and check patient diaries.
Treatment compliance will be evaluated at Visit 3. 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 Treatment".
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 204 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Materia Medica Holding is the lead sponsor of 42 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Drug: Anaferon
Placebo using Anaferon regimen until the end of the study.
Drug: Placebo
Oral administration.
Oral administration.
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms.
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).
Time frame: On days 1-7 of the observation period.
ARVI Severity.
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).
Time frame: On days 1-6 of the observation period.
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
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).
Time frame: On day 2, 3, 4, 5, and 6.
Time to Resolution of ARVI (PCR-confirmed) Symptoms.
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).
Time frame: On days 2-6 of the observation period.
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
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).
Time frame: On day 2, 3, 4, 5, and 6.
Dosing Frequency of Antipyretics if Indicated.
Based on patient diary data. Dosing frequency is calculated as the number of antipyretic doses per 1 patient in a day.
Time frame: On day 1, 2, and 3.
The Percentage of Patients Requiring Administration of Antibiotics.
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.
Time frame: On days 4-7 of the observation period.
| Milestone | Anaferon | Placebo |
|---|---|---|
| Started | 104 | 100 |
| Completed | 103 | 100 |
| Not completed | 1 | 0 |
| Withdrew: Violation of inclusion criteria | 1 | 0 |
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).
| days | Anaferon | Placebo |
|---|---|---|
| Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms. | 4.1 ± 1.6 | 4.5 ± 1.5 |
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).
| day*score | Anaferon | Placebo |
|---|---|---|
| ARVI Severity. | 104.6 ± 43.5 | 114.3 ± 45.7 |
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).
| Participants | Anaferon | Placebo |
|---|---|---|
| Day 2 | 0 | 0 |
| Day 3 | 11 | 6 |
| Day 4 | 39 | 25 |
| Day 5 | 57 | 43 |
| Day 6 | 76 | 64 |
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).
| days | Anaferon | Placebo |
|---|---|---|
| Time to Resolution of ARVI (PCR-confirmed) Symptoms. | 3.6 ± 1.5 | 4.6 ± 1.5 |
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).
| Participants | Anaferon | Placebo |
|---|---|---|
| Day 2 | 0 | 0 |
| Day 3 | 7 | 4 |
| Day 4 | 22 | 10 |
| Day 5 | 29 | 14 |
| Day 6 | 35 | 23 |
Based on patient diary data. Dosing frequency is calculated as the number of antipyretic doses per 1 patient in a day.
| doses | Anaferon | Placebo |
|---|---|---|
| Day 1 | 0.4 ± 0.6 | 0.4 ± 0.6 |
| Day 2 | 0.2 ± 0.4 | 0.2 ± 0.4 |
| Day 3 | 0.1 ± 0.3 | 0.1 ± 0.3 |
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.
| Participants | Anaferon | Placebo |
|---|---|---|
| The Percentage of Patients Requiring Administration of Antibiotics. | 4 | 5 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anaferon | 0/104 (0%) | 0/104 (0%) | 5/104 (4.8%) |
| Placebo | 0/100 (0%) | 0/100 (0%) | 5/100 (5%) |
| Event | Anaferon | Placebo |
|---|---|---|
| Acute bronchitisRespiratory, thoracic and mediastinal disorders | 3/104 | 2/100 |
| Intoxication Syndrome IntensificationGeneral disorders | 0/104 | 1/100 |
| Community-acquired pneumoniaInfections and infestations | 0/104 | 1/100 |
| Acute tracheobronchitisInfections and infestations | 0/104 | 1/100 |
| Acute tracheitisInfections and infestations | 0/104 | 1/100 |
| Community-acquired bacterial infection with bacterial bronchitisInfections and infestations | 1/104 | 0/100 |
| Community-acquired bacterial infection with purulent rhinitisInfections and infestations | 1/104 | 0/100 |
| HeadacheNervous system disorders | 1/104 | 0/100 |
| Age, Categorical(Participants) | Anaferon | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 103 | 100 | 203 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Anaferon | Placebo | Total |
|---|---|---|---|
| Mean | 39.1 ± 13.4 | 37.8 ± 11.9 | 38.5 ± 12.7 |
| Sex: Female, Male(Participants) | Anaferon | Placebo | Total |
|---|---|---|---|
| Female | 66 | 73 | 139 |
| Male | 37 | 27 | 64 |
| Race and Ethnicity Not Collected(Participants) | Anaferon | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Anaferon | Placebo | Total |
|---|---|---|---|
| Russia | 103 | 100 | 203 |
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