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

Primary Purpose

Viral Respiratory Infection

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

MMH-407

Placebo

About this trial

This is an interventional treatment trial for Viral Respiratory Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of either gender aged 18-70 years.
Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2.
The first 24 hours after ARVI onset.
Patients giving their consent to use reliable contraception during the study.
Signed patient information sheet (informed consent form).

Exclusion Criteria:

Clinical symptoms of severe influenza/ARVI requiring hospitalization.
Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology).
Patients requiring antiviral medication prohibited within the study.
Medical history of primary and secondary immunodeficiency.
Medical history/suspicion of oncology of any localization (except for benign neoplasms).
Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
Allergy/ hypersensitivity to any component of the study drug.
Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.
Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures.
Participation in other clinical trials for 3 months prior to enrollment in this study.
Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Sites / Locations

Altai State Medical University, Department of Faculty Therapy with a course of immunology and allergology
City Hospital #5
Belgorod State National Research University, Hospital Therapy Department
Road Clinical Hospital at Chelyabinsk station of JSC Russian Railways
City Clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
Kazan State Medical University, Internal Medicine Department
Kazan State Medical University, Professorial clinic
Kuban State Medical University, Infectious Diseases and PhthisiopulmonologyDepartment
Central Clinical Hospital of the Russian Academy of Sciences
Moscow State Medical and Dental University named after A.I. Evdokimov, Pulmonology Laboratory
Road Clinical Hospital at the station Nizhny Novgorod of JSC Russian Railways
City Clinical Hospital #10 of the Kanavinsky District of Nizhny Novgorod
Podolsk City Clinical Hospital # 3
City Emergency Hospital Rostov-on-Don
Ryazan State Medical University named after academician I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine
Vvedensky City Clinical Hospital
City Polyclinic #25 of the Nevsky District
Medical Center "Reavita Med SPb"
Road Clinical Hospital of JSC Russian Railways
City Polyclinic #51
City Polyclinic #34
City Polyclinic #43
Samara City Hospital #4
Scientific Medical Center for General Therapy and Pharmacology
Bashkir State Medical University, Internal Medicine Department
Volgograd State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MMH-407

Placebo

Arm Description

Tablet for oral use. One tablet per intake. On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. The drug is administered not during meals (i.e. between the meals or 15-30 minutes before meal). The tablet should be held in mouth until complete dissolution.

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

Outcomes

Primary Outcome Measures

Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms

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".

Secondary Outcome Measures

Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)

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.

Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)

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 to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)

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".

Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)

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".

Dosing Frequency of Antipyretics.

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

Percentage of Patients Reporting Worsening of Illness

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

Occurrence and Characteristics of Adverse Events (AEs)

Severity of AEs, its causal relationship to the study drug, and outcomes.

Changes in Vital Signs: Blood Pressure.

Outcome Measure is based on the medical records. Blood Pressure was measured by the physician in every visit (on days 1, 5, and 7).

Changes in Vital Signs: Pulse Rate (Heart Rate).

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).

Changes in Vital Signs: Respiration Rate (Breathing Rate).

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).

Percentage of Patients With Clinically Relevant Laboratory Abnormalities

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

Full Information

NCT ID

NCT04244084

First Posted

December 13, 2019

Last Updated

April 28, 2022

Sponsor

Materia Medica Holding

1. Study Identification

Unique Protocol Identification Number

NCT04244084

Brief Title

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

Official Title

Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of MMH-407 in the Treatment of Acute Respiratory Viral Infection

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

October 8, 2019 (Actual)

Primary Completion Date

April 9, 2020 (Actual)

Study Completion Date

April 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Materia Medica Holding

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).

Detailed Description

Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial. The study will enroll outpatients of either gender aged 18-70 years old with clinical manifestations of ARVI within the first day after the onset of the disease during seasonal ARVI morbidity. After signing patient information sheet and informed consent form, medical history, thermometry, objective examination, laboratory tests and concomitant medication will be performed. Severity of ARVI symptoms is evaluated with 4-point scale. The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI. 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 will take MMH-407 according to the dosage regimen for 5 days; the 2nd group will take Placebo according to MMH-407 dosage regimen for 5 days. The study will use electronic patient diary for recording morning and evening axillary body temperature (measured using a mercury-free Geratherm Classic thermometer) and disease symptoms (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any aggravation in a patient's condition (if applicable, for safety evaluation/AE documentation) will also be recorded in a patient diary. The investigator will provide instructions on filling the diary; at Visit 1 the patient together with a doctor will record ARVI symptom severity and body temperature in the diary. Patient will be observed for 14 days (screening, randomization - Day 1, treatment period - 5 days, follow-up - up to 2 days; deferred "phone visit" - Day 14). During the treatment and follow-up period the patients or investigators will make 3 visits and the fourth "phone visit" will be scheduled additionally: 1) visits by physician/patient - on Days 1, 5 and 7 (Visits 1, 2 and 3) - in a study center or at home; 2) "phone visit" (Visit 4) - on Day 14. At Visits 2 and 3, the investigator will perform an objective examination, document changes in the symptoms and concomitant medications to check patient diaries. At Visit 3 compliance will be evaluated and laboratory tests will be performed. "Phone visit" is carried out to interview the patient about his/her condition, presence/absence of secondary bacterial/viral complications and use of antibiotics. During the study, symptomatic therapy and therapy for their co-morbidities are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Viral Respiratory Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MMH-407

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MMH-407

Other Intervention Name(s)

Raphamin

Intervention Description

Oral use.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral use.

Primary Outcome Measure Information:

Title

Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms

Description

Time Frame

14 days of observation.

Secondary Outcome Measure Information:

Title

Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)

Description

Time Frame

On days 1- 6 of the observation.

Title

Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)

Description

Time Frame

On days 3, 4, 5 and 6 of observation.

Title

Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)

Description

Time Frame

14 days of observation.

Title

Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)

Description

Time Frame

On days 3, 4, 5 and 6 of observation.

Title

Dosing Frequency of Antipyretics.

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.

Title

Percentage of Patients Reporting Worsening of Illness

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.

Title

Occurrence and Characteristics of Adverse Events (AEs)

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.

Title

Changes in Vital Signs: Blood Pressure.

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.

Title

Changes in Vital Signs: Pulse Rate (Heart Rate).

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.

Title

Changes in Vital Signs: Respiration Rate (Breathing Rate).

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.

Title

Percentage of Patients With Clinically Relevant Laboratory Abnormalities

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of either gender aged 18-70 years. Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2. The first 24 hours after ARVI onset. Patients giving their consent to use reliable contraception during the study. Signed patient information sheet (informed consent form). Exclusion Criteria: Clinical symptoms of severe influenza/ARVI requiring hospitalization. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology). Patients requiring antiviral medication prohibited within the study. Medical history of primary and secondary immunodeficiency. Medical history/suspicion of oncology of any localization (except for benign neoplasms). Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. Allergy/ hypersensitivity to any component of the study drug. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study. Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view. Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures. Participation in other clinical trials for 3 months prior to enrollment in this study. Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Facility Information:

Facility Name

Altai State Medical University, Department of Faculty Therapy with a course of immunology and allergology

City

Barnaul

ZIP/Postal Code

656038

Country

Russian Federation

Facility Name

City Hospital #5

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Belgorod State National Research University, Hospital Therapy Department

City

Belgorod

ZIP/Postal Code

308015

Country

Russian Federation

Facility Name

Road Clinical Hospital at Chelyabinsk station of JSC Russian Railways

City

Chelyabinsk

ZIP/Postal Code

454000

Country

Russian Federation

Facility Name

City Clinical Hospital #9 of the Ministry of Health of the Udmurt Republic

City

Izhevsk

ZIP/Postal Code

426063

Country

Russian Federation

Facility Name

Kazan State Medical University, Internal Medicine Department

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Kazan State Medical University, Professorial clinic

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Kuban State Medical University, Infectious Diseases and PhthisiopulmonologyDepartment

City

Krasnodar

ZIP/Postal Code

350063

Country

Russian Federation

Facility Name

Central Clinical Hospital of the Russian Academy of Sciences

City

Moscow

ZIP/Postal Code

117593

Country

Russian Federation

Facility Name

Moscow State Medical and Dental University named after A.I. Evdokimov, Pulmonology Laboratory

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

Road Clinical Hospital at the station Nizhny Novgorod of JSC Russian Railways

City

Nizhniy Novgorod

ZIP/Postal Code

603140

Country

Russian Federation

Facility Name

City Clinical Hospital #10 of the Kanavinsky District of Nizhny Novgorod

City

Nizhny Novgorod

ZIP/Postal Code

603011

Country

Russian Federation

Facility Name

Podolsk City Clinical Hospital # 3

City

Podolsk

ZIP/Postal Code

142105

Country

Russian Federation

Facility Name

City Emergency Hospital Rostov-on-Don

City

Rostov-on-Don

ZIP/Postal Code

344068

Country

Russian Federation

Facility Name

Ryazan State Medical University named after academician I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Vvedensky City Clinical Hospital

City

Saint Petersburg

ZIP/Postal Code

191180

Country

Russian Federation

Facility Name

City Polyclinic #25 of the Nevsky District

City

Saint Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Medical Center "Reavita Med SPb"

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Road Clinical Hospital of JSC Russian Railways

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

City Polyclinic #51

City

Saint Petersburg

ZIP/Postal Code

196211

Country

Russian Federation

Facility Name

City Polyclinic #34

City

Saint Petersburg

ZIP/Postal Code

197198

Country

Russian Federation

Facility Name

City Polyclinic #43

City

Saint Petersburg

ZIP/Postal Code

198207

Country

Russian Federation

Facility Name

Samara City Hospital #4

City

Samara

ZIP/Postal Code

443056

Country

Russian Federation

Facility Name

Scientific Medical Center for General Therapy and Pharmacology

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Bashkir State Medical University, Internal Medicine Department

City

Ufa

ZIP/Postal Code

450008

Country

Russian Federation

Facility Name

Volgograd State Medical University

City

Volgograd

ZIP/Postal Code

400131

Country

Russian Federation

12. IPD Sharing Statement

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

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