Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections
Condition: Acute Respiratory Viral Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose of the study:

      • To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute
      respiratory viral infections.
    

Detailed description: 
      Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial.

      The study will enroll patients of either gender aged 18-70 years old with clinical
      manifestations of ARVI within the first day after the onset of the disease. Signed
      information sheet for patient will be obtained from all participants prior to the screening
      procedures. Medical history, concomitant medication, thermometry, patient examination by a
      doctor, assessment of ARVI symptoms severity will be performed at screening visit.

      The nasopharyngeal swabs will be performed for Real-time reverse transcription polymerase
      chain reaction (PCR) assay to confirm viral etiology of ARVI and to verify respiratory
      viruses prior to the therapy.

      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 patients will take
      Anaferon according to the dosage regimen until the end of the study; the 2nd group patients
      will take Placebo according to Anaferon dosage regimen until the end of the study.

      The patients will be provided with a patient diary (paper or electronic) where daily they
      will record axillary body temperature (using a Geratherm Classic thermometer) and each ARVI
      symptom severity twice a day (in the morning and in the evening). In addition, antipyretic
      administration (if applicable) as well as any possible worsening of the patient's condition
      (if applicable, for safety evaluation/AEs documentation) will also be recorded in a patient
      diary. An investigator will provide the instructions on filling out the diary and will help
      the patient to make first records of ARVI symptom severity and body temperature in the diary.

      Patients are observed up for 7 days (screening, randomization - 1 day, study therapy - 5
      days, follow-up period - 2 days). During treatment and follow-up period two visits are
      scheduled (at home or at the study site) on days 5 (Visit 2) and day 7 (Visit 3). At Visits 2
      and 3, the investigator will carry out physical examination, record dynamics of ARVI symptoms
      and concomitant therapy and check patient diaries.

      Treatment compliance will be evaluated at Visit 3. During the study, symptomatic therapy and
      therapy for underlying chronic conditions are allowed with the exception of the drugs
      indicated in the section "Prohibited Concomitant Treatment".
    

Intervention name(s): Anaferon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment