Trial Outcomes & Findings for Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years Old (NCT NCT04918771)

NCT ID: NCT04918771

Last Updated: 2024-10-15

Results Overview

Outcome Measure is evaluated on the basis of ARVI, confirmed by Polymerase chain reaction (PCR), i.e virus detection. ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 435 participants
• Primary outcome timeframe: 14 days of observation
• Results posted on: 2024-10-15

Participant Flow

A total of 435 patients signed informed consent, of which 10 patients did not pass screening (not meet inclusion criteria or non-inclusion criteria). 5 patients had significant deviations from the procedure for signing informed consent. However, they were randomized and received study therapy. But these patients are not counted as randomized.

Participant milestones

Measure	Raphamin Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Overall Study STARTED	206	214
Overall Study COMPLETED	199	205
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Measure	Raphamin Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Overall Study Withdrawal by Subject	4	5
Overall Study Incorrect inclusion ineligible patient	3	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Raphamin n=199 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=205 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.	Total n=404 Participants Total of all reporting groups
Age, Continuous	14.3 years STANDARD_DEVIATION 1.7 • n=199 Participants	14.2 years STANDARD_DEVIATION 1.7 • n=205 Participants	14.2 years STANDARD_DEVIATION 1.7 • n=404 Participants
Age, Customized 12 to 18 years	199 Participants n=199 Participants	205 Participants n=205 Participants	404 Participants n=404 Participants
Sex: Female, Male Female	100 Participants n=199 Participants	107 Participants n=205 Participants	207 Participants n=404 Participants
Sex: Female, Male Male	99 Participants n=199 Participants	98 Participants n=205 Participants	197 Participants n=404 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	199 participants n=199 Participants	205 participants n=205 Participants	404 participants n=404 Participants

PRIMARY outcome

Timeframe: 14 days of observation

Outcome Measure is evaluated on the basis of ARVI, confirmed by Polymerase chain reaction (PCR), i.e virus detection.

ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.

Outcome measures

Measure	Raphamin n=122 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=107 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms (ARVI, Confirmed by Polymerase Chain Reaction (PCR)).	3.3 day Standard Deviation 1.7	4.4 day Standard Deviation 2.6

SECONDARY outcome

Timeframe: Day1 through Day6 of the treatment and observation

Population: Two subpopulations were analysed: 1. Patients with clinically diagnosed and/or PCR-confirmed ARVI. 2. Patients with PCR-confirmed ARVI strictly.

The outcome measure is based on the area under the curve (AUC) for the TSS (Total symptoms score).

TSS is calculated as a sum of scores for 14 different symptoms. 13 of them are different ARVI manifestations, each of them is evaluated on a scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). 14th symptom is body temperature (temp) which is converted to its score using following rules:

if temp <= 37.3 then score = 0 (none) if 37.3 < temp <= 38.0 then score = 1 (mild) if 38.0 < temp <= 39.0 then score = 2 (moderate) if 39.0 < temp then score = 3 (severe) So it is 14 symptoms and the score for each of them varies between 0 and 3. Minimum TSS is 0, maximum is 42 (higher TSS score is worse). AUC is calculated for all timepoints available for patient.

Outcome measures

Measure	Raphamin n=199 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=205 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed). Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed), AUC score	44.6 scores on a scale*days Standard Deviation 23.8	46.9 scores on a scale*days Standard Deviation 24.3
Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed). Severity of ARVI (PCR-confirmed), AUC score	48.3 scores on a scale*days Standard Deviation 25.2	53.6 scores on a scale*days Standard Deviation 25.6

SECONDARY outcome

Timeframe: 14 days of observation

ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.

Outcome measures

Measure	Raphamin n=199 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=205 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed). Day 4	96 Participants	94 Participants
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed). Day 5	149 Participants	136 Participants
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed). Day 2	24 Participants	16 Participants
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed). Day 3	64 Participants	46 Participants
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed). Day 6	174 Participants	162 Participants
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed). Day 7	191 Participants	181 Participants

SECONDARY outcome

Timeframe: 14 days of observation

ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.

Outcome measures

Measure	Raphamin n=199 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=205 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Time to Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).	3.4 day Standard Deviation 1.8	3.9 day Standard Deviation 2.4

SECONDARY outcome

Timeframe: 14 days of observation

Outcome Measure is based on the Percentage of Patients With Resolution of ARVI, confirmed by Polymerase chain reaction (PCR), i.e virus detection.

ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.

Outcome measures

Measure	Raphamin n=122 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=107 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed). Day 2	16 Participants	4 Participants
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed). Day 3	36 Participants	16 Participants
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed). Day 4	59 Participants	39 Participants
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed). Day 5	95 Participants	64 Participants
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed). Day 6	107 Participants	77 Participants
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed). Day 7	119 Participants	89 Participants

SECONDARY outcome

Timeframe: 3 days of therapy

Outcome Measure is based on the rates of antipyretic use per patient during days 1 to 3 of therapy according to the electronic patient diary.

Outcome measures

Measure	Raphamin n=199 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=205 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Dosing Frequency of Antipyretics. Day 1	0.43 number of doses Standard Deviation 0.72	0.39 number of doses Standard Deviation 0.72
Dosing Frequency of Antipyretics. Day 2	0.22 number of doses Standard Deviation 0.61	0.25 number of doses Standard Deviation 0.66
Dosing Frequency of Antipyretics. Day 3	0.09 number of doses Standard Deviation 0.38	0.07 number of doses Standard Deviation 0.31

SECONDARY outcome

Timeframe: Day 4 through day 14 of the treatment and observation period

Outcome Measure is based on the rates of Complications that require the use of antibiotics or hospitalization.

Outcome measures

Measure	Raphamin n=199 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=205 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Percentage of Patients Reporting Worsening of Illness.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days of observation

1. The intensity (severity) of adverse events.

2. Causal relationship of AEs to the sudy drug.

3. Outcome of AEs. Based on medical records.

Outcome measures

Measure	Raphamin n=206 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. Outcome/Recovery	6 number of cases	5 number of cases
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. Severity/Mild	2 number of cases	6 number of cases
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. Severity/Moderate	5 number of cases	0 number of cases
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. Causal relationship/Not connected	7 number of cases	6 number of cases
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity. Outcome/Unknown	1 number of cases	1 number of cases

SECONDARY outcome

Timeframe: Day 1 through day 7 of the treatment and observation period.

Population: Only non-missing values were analyzed, so numbers analyzed are a bit lower then overall number of participants for visits 2 and 3.

The outcome measure is based on the medical records. The patient's heart rate (heart rate) is measured by the physician in every visit (on days 1, 5, and 7).

Outcome measures

Measure	Raphamin n=206 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Changes in Vital Signs: Pulse Rate/Heart Rate in Beats Per Minute (Bpm). Visit 1	87.1 beats per minute Standard Deviation 11.4	87.2 beats per minute Standard Deviation 10.6
Changes in Vital Signs: Pulse Rate/Heart Rate in Beats Per Minute (Bpm). Visit 2	77.9 beats per minute Standard Deviation 7.1	78.1 beats per minute Standard Deviation 7.2
Changes in Vital Signs: Pulse Rate/Heart Rate in Beats Per Minute (Bpm). Visit 3	76.3 beats per minute Standard Deviation 7.0	76.7 beats per minute Standard Deviation 6.8

SECONDARY outcome

Timeframe: Day 1 through day 7 of the treatment and observation period.

Population: Only non-missing values were analyzed, so numbers analyzed are a bit lower then overall number of participants for visits 2 and 3.

Outcome Measure is based on the medical records. The patient's respiration rate (breathing rate) is measured by physician in every visit (on days 1, 5, and 7).

Outcome measures

Measure	Raphamin n=206 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Changes in Vital Signs: Respiration Rate/Breathing Rate in Breaths Per Minute. Visit 1	20.8 breaths per minute Standard Deviation 3.3	20.7 breaths per minute Standard Deviation 2.8
Changes in Vital Signs: Respiration Rate/Breathing Rate in Breaths Per Minute. Visit 2	18.4 breaths per minute Standard Deviation 1.9	18.6 breaths per minute Standard Deviation 1.7
Changes in Vital Signs: Respiration Rate/Breathing Rate in Breaths Per Minute. Visit 3	18.0 breaths per minute Standard Deviation 1.7	18.2 breaths per minute Standard Deviation 1.7

SECONDARY outcome

Timeframe: Day 1 through day 7 of the treatment and observation period.

Population: Only non-missing values were analyzed, so numbers analyzed are a bit lower then overall number of participants for visits 2 and 3.

Outcome Measure is based on the medical records. The patient's blood pressure is measured by the physician in every visit (on days 1, 5, and 7).

Outcome measures

Measure	Raphamin n=206 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg). Visit 1/Systolic blood pressure	112 mmHg Standard Deviation 9.9	112 mmHg Standard Deviation 8.9
Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg). Visit 2/Systolic blood pressure	111 mmHg Standard Deviation 9.8	112 mmHg Standard Deviation 8.7
Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg). Visit 3/Systolic blood pressure	111 mmHg Standard Deviation 10.2	111 mmHg Standard Deviation 9.4
Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg). Visit 1/Diastolic blood pressure	70.0 mmHg Standard Deviation 5.7	69.8 mmHg Standard Deviation 5.8
Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg). Visit 2/Diastolic blood pressure	69.7 mmHg Standard Deviation 5.7	69.5 mmHg Standard Deviation 5.4
Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg). Visit 3/Diastolic blood pressure	69.6 mmHg Standard Deviation 5.7	69.4 mmHg Standard Deviation 5.9

SECONDARY outcome

Timeframe: Day 1 through day 7 of the treatment and observation period.

Outcome Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values at the end of treatment.

Outcome measures

Measure	Raphamin n=206 Participants Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 Participants Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Percentage of Patients With Clinically Relevant Abnormal Laboratory Findings.	1 Participants	0 Participants

Adverse Events

Raphamin

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raphamin n=206 participants at risk Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 participants at risk Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Infections and infestations Worsening flu	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.

Other adverse events

Measure	Raphamin n=206 participants at risk Tablet for oral use. Raphamin: Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.	Placebo n=214 participants at risk Tablet for oral use. Placebo: Oral administration - not with food. Placebo using Raphamin scheme.
Infections and infestations Adenoiditis	0.00% 0/206 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.47% 1/214 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Infections and infestations Bacterial superinfection	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Infections and infestations Viral upper respiratory tract infection	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Infections and infestations Coronavirus infection COVID-19	0.00% 0/206 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.47% 1/214 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Investigations Increased percentage of monocytes	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/206 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.47% 1/214 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Blood and lymphatic system disorders Anemia	0.00% 0/206 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.47% 1/214 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/206 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.47% 1/214 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Nervous system disorders Dizziness	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Nervous system disorders Loss of consciousness	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Vascular disorders Pallor	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.00% 0/214 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.
Infections and infestations Flu	0.49% 1/206 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.	0.47% 1/214 • Number of events 1 • Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 14 days.

Additional Information

Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director

MATERIA MEDICA HOLDING

Phone: +74952761571

Email: PutilovskiyMA@materiamedica.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place