Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection
Condition: Viral Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Virus Diseases
Intervention: MMH-407; Placebo
Intervention description: Oral use.; Oral use.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either gender aged 18-70 years.

          2. 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.

          3. The first 24 hours after ARVI onset.

          4. Patients giving their consent to use reliable contraception during the study.

          5. Signed patient information sheet (informed consent form).

        Exclusion Criteria:

          1. Clinical symptoms of severe influenza/ARVI requiring hospitalization.

          2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary
             tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics
             from the first day of illness.

          3. 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).

          4. Patients requiring antiviral medication prohibited within the study.

          5. Medical history of primary and secondary immunodeficiency.

          6. Medical history/suspicion of oncology of any localization (except for benign
             neoplasms).

          7. Aggravation or decompensation of chronic diseases affecting a patient's ability to
             participate in the clinical trial.

          8. Malabsorption syndrome, including congenital or acquired lactase or other
             disaccharidase deficiency, galactosemia.

          9. Allergy/ hypersensitivity to any component of the study drug.

         10. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the
             trial, unwillingness to use contraceptive methods during the trial.

         11. Course administration of the drug products specified in the section "Prohibited
             Concomitant Therapy" within two weeks prior to inclusion in the study.

         12. 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.

         13. Medical history of mental diseases, alcoholism or drug abuse that according to the
             investigator's opinion will compromise compliance with the study procedures.

         14. Participation in other clinical trials for 3 months prior to enrollment in this study.

         15. 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).

         16. 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).