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
Study type: Interventional
Phase: Phase 3

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".
    

Intervention name(s): MMH-407; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral use.; Oral use.
Other intervention name(s): Raphamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment