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

Last updated: August 15, 2023
Sponsor: Materia Medica Holding
Overall Status: Suspended

Phase

3

Condition

Influenza

Treatment

MMH-407

Placebo

Clinical Study ID

NCT04250311
MMH-407-002
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients of male and female gender aged 18 to 64 years.
  2. 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, sorethroat, or nasal congestion).
  1. Positive influenza rapid test (detection of virus antigens in the nasal epithelium).
  2. First 24 hours of the onset of illness.
  3. Patients who agree to use a reliable method of birth control during the study.
  4. Patients who have provided signed Participant Information Sheet and Informed Consentform to participate in a clinical trial.

Exclusion

Exclusion Criteria:

  1. Severe influenza infection that requires hospitalization.
  2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinarytract infection, meningitis, sepsis, etc.) that requires the use of antibiotics,starting from the first day of illness.
  3. Suspected early manifestations of a condition that, on its first onset, producessymptoms similar to those of influenza (other infectious diseases and/orinfluenza-like syndrome associated with the first onset of a systemic connectivetissue disorder or another condition).
  4. Patients who require the use of antivirals that are not permitted during the study.
  5. Current season influenza vaccination.
  6. Prior history or diagnosis of primary or secondary immunodeficiency
  7. Patients with any known or suspected malignant neoplasm.
  8. An exacerbated or decompensated chronic disease interfering with the subject'sparticipation in the clinical trial.
  9. Malabsorption syndrome, including congenital or acquired lactase deficiency (or anyother disaccharidase deficiency), and/or galactosemia.
  10. Current allergy to or intolerance of the active substances or any of the excipients inthe medications used in the treatment.
  11. Pregnancy, breast-feeding, childbirth within less than 3 months prior to the inclusionin the trial, or unwillingness to use contraceptive methods during the study
  12. Prior history of non-adherence to medication; mental disorder; or alcohol or substanceabuse, which, in the investigator's opinion, will compromise compliance with studyprocedures.
  13. Use of any of the "Prohibited Concomitant Medications" within 2 weeks prior to studyentry.
  14. Patients who, as judged by the investigator, will fail or be unwilling to comply withthe observation requirements or adhere to the dosing regimen during the study.
  15. Participation in other clinical studies within 3 months prior to the inclusion in thisstudy.
  16. Patients who are related to any of the on-site research personnel directly involved inthe conduct of the study or are an immediate relative of the investigator. 'Immediaterelative' means husband, wife, parent, son, daughter, brother, or sister (regardlessof whether they are natural or adopted).
  17. Patients who work for OOO "NPF "Materia Medica Holding" (i.e. company employees,temporary contract workers, designated officials responsible for carrying out theresearch or any immediate relatives of the aforementioned).

Study Design

Total Participants: 314
Treatment Group(s): 2
Primary Treatment: MMH-407
Phase: 3
Study Start date:
December 12, 2019
Estimated Completion Date:
December 31, 2024

Study Description

Design: a multicenter, placebo-controlled, double-blind, randomized clinical trial in parallel groups.

The study will include both male and female patients aged 18-64 years with clinical signs of influenza within the first 24 hours of the onset of illness.

The influenza diagnosis must be supported by a positive rapid test (detection of influenza virus antigens in nasal epithelial cells). After the patients provide signed Participant Information Sheet and Informed Consent form, their medical history and body temperature will be recorded and physical examination and rapid diagnostic test performed. Patients who test positive will be assessed for 7 influenza-associated symptoms: cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, fatigue.

4-point Flu Symptom Severity scale will be used: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom.

Nasopharyngeal swabs will be obtained from these patients for subsequent real-time reverse transcription polymerase chain reaction (RT-PCR) influenza A/B testing and laboratory tests performed.

If a patient meets all inclusion criteria and does not meet any of the exclusion criteria at Visit 1 (Day 1), he/she will be randomized into one of the treatment groups: Group 1: ММН-407 for 5 days, or Group 2: Placebo on the ММН-407 regimen for 5 days.

The patients will use electronic patient diaries to daily record their morning and evening axillary temperature (taken using a Geratherm mercury-free thermometer) and severity of 7 influenza-associated symptoms (using the Flu Symptom Severity scale). In addition to this, the patients will record doses of antipyretic drugs taken (when applicable) and any worsening of their health status (when applicable, to assess treatment safety and collect adverse events data).

In total, patients will be observed for 14 days (screening and randomization - up to 24 hours, treatment - 5 days, subsequent observation - up to 2 days; and a follow-up 'telephone' visit - Day 14).

During the study, 3 visits from patient to the physician's office and a follow-up telephone visit will be accomplished: 1) patient visits - Days 1, 3 and 7 (Visits 1, 2, and 3) at the medical centre; 2) telephone visit from the physician (Visit 4) - Day 14.

During Visits 2 and 3, the physician will perform a physical examination, record the changes in patients' symptoms and the use of concomitant medications and check the completion of patient diaries. At Visit 2, nasopharyngeal swabs for RT-PCR will be collected. Visit 3 will involve an assessment of treatment compliance and laboratory tests. The telephone visit is intended to provide information on a patient's health status, presence/absence of secondary bacterial complications and the use of antibiotics.

During the study, subjects will be allowed to use symptomatic therapy and medications for their co-morbidities, except for the medicines listed in the "Prohibited Concomitant Medications" section.

Connect with a study center

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

    Barnaul, Москва 656038
    Russian Federation

    Site Not Available

  • City Hospital # 5

    Barnaul, 656045
    Russian Federation

    Site Not Available

  • Belgorod State National Research University, Hospital Therapy Department

    Belgorod, 308015
    Russian Federation

    Site Not Available

  • Road Clinical Hospital at Chelyabinsk station of JSC Russian Railways

    Chelyabinsk, 454000
    Russian Federation

    Site Not Available

  • Central City Hospital # 7

    Ekaterinburg, 620137
    Russian Federation

    Site Not Available

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

    Izhevsk, 426063
    Russian Federation

    Site Not Available

  • Kazan State Medical University

    Kazan, 420012
    Russian Federation

    Site Not Available

  • Kazan State Medical University, Internal Medicine Department

    Kazan, 420012
    Russian Federation

    Site Not Available

  • Kirov State Medical University, Clinic of Kirov State Medical University

    Kirov, 610027
    Russian Federation

    Site Not Available

  • Kirov State Medical University, Hospital Therapy Department

    Kirov, 610027
    Russian Federation

    Site Not Available

  • Kuban State Medical University, Infectious Diseases and Phthisiopulmonology Department

    Krasnodar, 350063
    Russian Federation

    Site Not Available

  • Central Clinical Hospital of the Russian Academy of Sciences

    Moscow, 117593
    Russian Federation

    Site Not Available

  • City Clinical Hospital #24

    Moscow, 127015
    Russian Federation

    Site Not Available

  • City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

    Moscow, 121374
    Russian Federation

    Site Not Available

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

    Moscow, 127473
    Russian Federation

    Site Not Available

  • Polyclinic # 5 of the Office of the President of the Russian Federation

    Moscow, 119121
    Russian Federation

    Site Not Available

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

    Nizhny Novgorod, 603011
    Russian Federation

    Site Not Available

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

    Nizhny Novgorod, 603140
    Russian Federation

    Site Not Available

  • Podolsk City Clinical Hospital # 3

    Podolsk, 142105
    Russian Federation

    Site Not Available

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

    Ryazan, 390026
    Russian Federation

    Site Not Available

  • City Polyclinic # 25 of the Nevsky District

    Saint Petersburg, 193312
    Russian Federation

    Site Not Available

  • City Polyclinic # 34

    Saint Petersburg, 197198
    Russian Federation

    Site Not Available

  • City Polyclinic # 4

    Saint Petersburg, 199178
    Russian Federation

    Site Not Available

  • City Polyclinic # 43

    Saint Petersburg, 198207
    Russian Federation

    Site Not Available

  • City Polyclinic # 51

    Saint Petersburg, 196211
    Russian Federation

    Site Not Available

  • Llc "Medical Clinic"

    Saint Petersburg, 194356
    Russian Federation

    Site Not Available

  • Medical Center "Reavita Med SPb"

    Saint Petersburg, 194354
    Russian Federation

    Site Not Available

  • Road Clinical Hospital of JSC Russian Railways

    Saint Petersburg, 195271
    Russian Federation

    Site Not Available

  • Vvedensky City Clinical Hospital

    Saint Petersburg, 191180
    Russian Federation

    Site Not Available

  • Samara City Hospital # 4

    Samara, 443056
    Russian Federation

    Site Not Available

  • Scientific Medical Center for General Therapy and Pharmacology

    Stavropol, 355000
    Russian Federation

    Site Not Available

  • Tver State Medical University, Department of Hospital Therapy

    Tver, 170100
    Russian Federation

    Site Not Available

  • Bashkir State Medical University, Internal Medicine Department

    Ufa, 450008
    Russian Federation

    Site Not Available

  • Volgograd State Medical University

    Volgograd, 400131
    Russian Federation

    Site Not Available

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