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

NCT04244084 | Completed Phase 3 Results

• 1 other identifier: MMH-407-001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

Viral Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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".

  14 days of observation.

Secondary Outcomes (11)

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

  On days 1- 6 of the observation.

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

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

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

  14 days of observation.

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

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

• Dosing Frequency of Antipyretics.

  On days 1, 2, 3 of therapy.

Study Arms (2)

MMH-407

EXPERIMENTAL

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.

Drug: MMH-407

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MMH-407 DRUG

Oral use.

Also known as: Raphamin

MMH-407

Placebo DRUG

Oral use.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (26)

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

Barnaul, 656038, Russia

Location

City Hospital #5

Barnaul, 656045, Russia

Location

Belgorod State National Research University, Hospital Therapy Department

Belgorod, 308015, Russia

Location

Road Clinical Hospital at Chelyabinsk station of JSC Russian Railways

Chelyabinsk, 454000, Russia

Location

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

Izhevsk, 426063, Russia

Location

Kazan State Medical University, Internal Medicine Department

Kazan', 420012, Russia

Location

Kazan State Medical University, Professorial clinic

Kazan', 420012, Russia

Location

Kuban State Medical University, Infectious Diseases and PhthisiopulmonologyDepartment

Krasnodar, 350063, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

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

Moscow, 127473, Russia

Location

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

Nizhny Novgorod, 603011, Russia

Location

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

Nizhny Novgorod, 603140, Russia

Location

Podolsk City Clinical Hospital # 3

Podolsk, 142105, Russia

Location

City Emergency Hospital Rostov-on-Don

Rostov-on-Don, 344068, Russia

Location

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

Ryazan, 390026, Russia

Location

Vvedensky City Clinical Hospital

Saint Petersburg, 191180, Russia

Location

City Polyclinic #25 of the Nevsky District

Saint Petersburg, 193312, Russia

Location

Medical Center "Reavita Med SPb"

Saint Petersburg, 194354, Russia

Location

Road Clinical Hospital of JSC Russian Railways

Saint Petersburg, 195271, Russia

Location

City Polyclinic #51

Saint Petersburg, 196211, Russia

Location

City Polyclinic #34

Saint Petersburg, 197198, Russia

Location

City Polyclinic #43

Saint Petersburg, 198207, Russia

Location

Samara City Hospital #4

Samara, 443056, Russia

Location

Scientific Medical Center for General Therapy and Pharmacology

Stavropol, 355000, Russia

Location

Bashkir State Medical University, Internal Medicine Department

Ufa, 450008, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: January 28, 2020
• Study Start: October 8, 2019
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: May 17, 2022
• Results First Posted: October 6, 2021

Record last verified: 2021-10

Locations

RU (26)