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Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04244084
Recruitment Status : Completed
First Posted : January 28, 2020
Results First Posted : October 6, 2021
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Viral Respiratory Infection
Interventions Drug: MMH-407
Drug: Placebo
Enrollment 240
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Period Title: Overall Study
Started 118 122
Completed 118 122
Not Completed 0 0
Arm/Group Title MMH-407 Placebo Total
Hide Arm/Group Description

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Total of all reporting groups
Overall Number of Baseline Participants 118 122 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 118 participants 122 participants 240 participants
38.5  (12.6) 38.5  (11.6) 38.5  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 122 participants 240 participants
Female
79
  66.9%
68
  55.7%
147
  61.3%
Male
39
  33.1%
54
  44.3%
93
  38.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russia Number Analyzed 118 participants 122 participants 240 participants
118 122 240
1.Primary Outcome
Title Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms
Hide Description

Outcome Measure is evaluated on the basis of the "ARVI severity scale" to calculate total symptom score (TSS) in patients with confirmed virus by Polymerase chain reaction (PCR).

ARVI's resolution criteria: temperature ≤37.3°С + TSS ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) 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. The range of TSS was from "0" to "39".

Time Frame 14 days of observation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 78 73
Mean (Standard Deviation)
Unit of Measure: days
4.1  (1.9) 5.0  (2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments Mean differences (MMH-407 vs. Placebo) were compared
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0155
Comments [Not Specified]
Method ANCOVA
Comments Site used as covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-1.61 to -0.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)
Hide Description Outcome Measure is based on the area under the curve (AUC) for TSS. AUC was calculated between 6 points (by TSS for every 6 days of the treatment and observation). The minimum value for the AUC was "0" and the maximum value was "234" units (day*score). Higher TSS and AUC scores meant worse results.
Time Frame On days 1- 6 of the observation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Mean (Standard Deviation)
Unit of Measure: day*score
48.5  (21.7) 52.6  (24.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1839
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Hide Description 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 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) 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. The range of TSS was from "0" to "39".
Time Frame On days 3, 4, 5 and 6 of observation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3
15
  12.7%
8
   6.6%
Day 4
44
  37.3%
38
  31.1%
Day 5
74
  62.7%
70
  57.4%
Day 6
86
  72.9%
85
  69.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0640
Comments Day used as independent strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Hide Description Acute Respiratory Viral Infection (ARVI) Symptoms 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 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) 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. The range of TSS was from "0" to "39".
Time Frame 14 days of observation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Mean (Standard Deviation)
Unit of Measure: days
4.4  (2.2) 4.8  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1927
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Hide Description

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

Acute Respiratory Viral Infection 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 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) 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. The range of TSS was from "0" to "39".

Time Frame On days 3, 4, 5 and 6 of observation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 78 73
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3
12
  15.4%
3
   4.1%
Day 4
28
  35.9%
22
  30.1%
Day 5
54
  69.2%
38
  52.1%
Day 6
60
  76.9%
48
  65.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments Day used as independent strata.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Dosing Frequency of Antipyretics.
Hide Description Outcome Measure is based on the rates of antipyretic use per patient during days 1 to 3 of therapy.
Time Frame On days 1, 2, 3 of therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Mean (Standard Deviation)
Unit of Measure: number of doses
Day 1 0.30  (0.68) 0.38  (0.67)
Day 2 0.19  (0.48) 0.24  (0.53)
Day 3 0.03  (0.22) 0.04  (0.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Day 1" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Day 2" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4717
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Day 3" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5144
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients Reporting Worsening of Illness
Hide Description Outcome Measure is based on the rates of Complications that require the use of antibiotics or hospitalization.
Time Frame From day 4 to day 14 of the observation period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.8%
3
   2.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Occurrence and Characteristics of Adverse Events (AEs)
Hide Description Severity of AEs, its causal relationship to the study drug, and outcomes.
Time Frame From day 1 to day 7 of the treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Measure Type: Number
Unit of Measure: Number of events
Number of AE 9 11
Mild severity 9 11
No relationship with the study drug 8 11
Probable relationship to study drug 1 0
9.Secondary Outcome
Title Changes in Vital Signs: Blood Pressure.
Hide Description Outcome Measure is based on the medical records. Blood Pressure was measured by the physician in every visit (on days 1, 5, and 7).
Time Frame On days 1, 5 and 7 of the treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure/Visit 1 121.0  (10.0) 121.0  (10.1)
Systolic blood pressure/Visit 2 120.0  (8.5) 120.0  (8.4)
Systolic blood pressure/Visit 3 120.0  (8.2) 119.0  (9.4)
Diastolic blood pressure/Visit 1 75.0  (7.5) 75.1  (7.3)
Diastolic blood pressure/Visit 2 74.9  (6.3) 74.8  (6.4)
Diastolic blood pressure/Visit 3 74.6  (6.6) 74.8  (7.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Systolic blood pressure/Visit 1" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5981
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Systolic blood pressure/Visit 2" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4913
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Systolic blood pressure/Visit 3" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6441
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Diastolic blood pressure/Visit 1" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8186
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Diastolic blood pressure/Visit 2" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8931
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Diastolic blood pressure/Visit 3" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5887
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title Changes in Vital Signs: Pulse Rate (Heart Rate).
Hide Description Outcome Measure is based on the medical records. Pulse Rate (Heart Rate) was measured by the physician in every visit (on days 1, 5, and 7).
Time Frame On days 1, 5 and 7 of the treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Mean (Standard Deviation)
Unit of Measure: bpm
Heart rate/Visit 1 86.9  (12.9) 88.0  (13.0)
Heart rate/Visit 2 73.5  (7.4) 74.4  (9.0)
Heart rate/Visit 3 71.1  (5.8) 71.7  (7.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Heart rate/Visit 1" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4426
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Heart rate/Visit 2" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5998
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Heart rate/Visit 3" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9710
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
11.Secondary Outcome
Title Changes in Vital Signs: Respiration Rate (Breathing Rate).
Hide Description Outcome Measure is based on the medical records. Respiration Rate (Breathing Rate) was measured by the physician in every visit (on days 1, 5, and 7).
Time Frame On days 1, 5 and 7 of the treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Mean (Standard Deviation)
Unit of Measure: breaths/min
Breathing rate/Visit 1 17.4  (1.6) 17.5  (1.6)
Breathing rate/Visit 2 16.6  (1.4) 16.7  (1.4)
Breathing rate/Visit 3 16.4  (1.3) 16.4  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Breathing rate/Visit 1" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6197
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Breathing rate/Visit 2" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7042
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments This analysis applies to "Breathing rate/Visit 3" row.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7693
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Patients With Clinically Relevant Laboratory Abnormalities
Hide Description Outcome Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which were beyond the reference values at the end of treatment.
Time Frame From day 1 to day 7 of the treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description:

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

Overall Number of Participants Analyzed 118 122
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMH-407, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MMH-407 Placebo
Hide Arm/Group Description

Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.

Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.

MMH-407: Oral administration.

According to the scheme of receiving MMN-407 until the end of the study.

Placebo: Oral administration.

All-Cause Mortality
MMH-407 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/118 (0.00%)      0/122 (0.00%)    
Hide Serious Adverse Events
MMH-407 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/118 (0.00%)      1/122 (0.82%)    
Infections and infestations     
Community-acquired pneumonia  1  0/118 (0.00%)  0 1/122 (0.82%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MMH-407 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/118 (7.63%)      9/118 (7.63%)    
Gastrointestinal disorders     
Epigastric pain  1  2/118 (1.69%)  2 0/118 (0.00%)  0
Diarrhea  1  0/118 (0.00%)  0 1/118 (0.85%)  1
Dry mouth  1  1/118 (0.85%)  1 0/118 (0.00%)  0
Nausea  1  0/118 (0.00%)  0 1/118 (0.85%)  1
General disorders     
Edema of the lips and face  1  0/118 (0.00%)  0 1/118 (0.85%)  1
Worsening of the disease  1  0/118 (0.00%)  0 1/118 (0.85%)  1
Infections and infestations     
Sinusitis  1  0/118 (0.00%)  0 1/118 (0.85%)  1
Purulent bronchitis  1  1/118 (0.85%)  1 1/118 (0.85%)  1
Acute nasopharyngitis  1  1/118 (0.85%)  1 0/118 (0.00%)  0
Acute tubootitis  1  1/118 (0.85%)  1 0/118 (0.00%)  0
Herpes simplex  1  1/118 (0.85%)  1 1/118 (0.85%)  1
Investigations     
Increase in the percentage of basophils  1  0/118 (0.00%)  0 1/118 (0.85%)  1
Increase in the percentage of eosinophils  1  0/118 (0.00%)  0 1/118 (0.85%)  1
Nervous system disorders     
Intercostal neuralgia  1  1/118 (0.85%)  1 0/118 (0.00%)  0
Migraine  1  1/118 (0.85%)  1 0/118 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Exacerbation of bronchial asthma  1  0/118 (0.00%)  0 1/118 (0.85%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
Organization: MATERIA MEDICA HOLDING
Phone: +74952761571 ext 302
EMail: PutilovskiyMA@materiamedica.ru
Layout table for additonal information
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT04244084    
Other Study ID Numbers: MMH-407-001
First Submitted: December 13, 2019
First Posted: January 28, 2020
Results First Submitted: May 24, 2021
Results First Posted: October 6, 2021
Last Update Posted: May 17, 2022