Clinical Trial of Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults

NCT04250311 | Suspended Phase 3

• 1 other identifier: MMH-407-002
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 20

Brief Summary

The main purpose of this study is: • to evaluate the efficacy and safety of MMH-407 in the treatment of influenza in outpatient adults.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to improvement of influenza symptoms.

  Based on patient diaries. In the morning and in the evening, the patients rate the severity of their symptoms on a 4-point scale (7 symptoms of influenza): headache, fever/chill, aches in the muscles/joints, weakness/drowsiness, cough, sore throat, and nasal congestion, where the absence of symptoms is 0, mild symptoms - 1, moderate symptoms - 2, and severe symptoms is 4. "Improvement of influenza symptoms" means no or mild symptoms.

  On days 1-14 of observation.

Secondary Outcomes (8)

• Proportion of patients reporting improvement of influenza symptoms.

  On days 1-14 of observation period.

• Severity of illness.

  On days 1- 6 of the observation period.

• Proportion of patients with negative virus shedding.

  On day 3 of the observation period.

• Dosing frequency of antipyretics according to indications.

  On days 1-3 of the treatment period.

• Proportion of subjects reporting worsening of illness.

  On days 4 -14 of the observation period.

Study Arms (2)

MMH-407

EXPERIMENTAL

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.

Drug: MMH-407

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

MMH-407 DRUG

MMH-407: For oral use.

Also known as: Raphamin

MMH-407

Placebo DRUG

Placebo: For oral use.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of male and female gender aged 18 to 64 years.
• Uncomplicated, moderate influenza supported by all the symptoms:
• axillary temperature ≥38.1°С on physician examination;
• at least one moderate general symptom of influenza infection (headache, fever/chill, aches in the muscles/joints, weakness/drowsiness);
• at least one moderate respiratory symptom of influenza infection (cough, sore throat, or nasal congestion).
• Positive influenza rapid test (detection of virus antigens in the nasal epithelium).
• First 24 hours of the onset of illness.
• Patients who agree to use a reliable method of birth control during the study.
• Patients who have provided signed Participant Information Sheet and Informed Consent form to participate in a clinical trial.

You may not qualify if:

• Severe influenza infection that requires hospitalization.
• Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) that requires the use of antibiotics, starting from the first day of illness.
• Suspected early manifestations of a condition that, on its first onset, produces symptoms similar to those of influenza (other infectious diseases and/or influenza-like syndrome associated with the first onset of a systemic connective tissue disorder or another condition).
• Patients who require the use of antivirals that are not permitted during the study.
• Current season influenza vaccination.
• Prior history or diagnosis of primary or secondary immunodeficiency
• Patients with any known or suspected malignant neoplasm.
• An exacerbated or decompensated chronic disease interfering with the subject's participation in the clinical trial.
• Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency), and/or galactosemia.
• Current allergy to or intolerance of the active substances or any of the excipients in the medications used in the treatment.
• Prior history of non-adherence to medication; mental disorder; or alcohol or substance abuse, which, in the investigator's opinion, will compromise compliance with study procedures.
• Use of any of the "Prohibited Concomitant Medications" within 2 weeks prior to study entry.
• Patients who, as judged by the investigator, will fail or be unwilling to comply with the observation requirements or adhere to the dosing regimen during the study.
• Patients who are related to any of the on-site research personnel directly involved in the conduct of 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. company 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 (20)

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

Barnaul, Moscow, 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

Kuban State Medical University, Infectious Diseases and Phthisiopulmonology Department

Krasnodar, 350063, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, 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

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

Llc "Medical Clinic"

Saint Petersburg, 194356, 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

Tver State Medical University, Department of Hospital Therapy

Tver', 170100, Russia

Location

Bashkir State Medical University, Internal Medicine Department

Ufa, 450008, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

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: January 29, 2020
• First Posted: January 31, 2020
• Study Start: December 12, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

RU (20)