<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840135</url>
  </required_header>
  <id_info>
    <org_study_id>PoArvi/PhIII_2017</org_study_id>
    <nct_id>NCT03840135</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI</brief_title>
  <official_title>A Multicenter Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged From 1 to 12 Years With ARI (Acute Respiratory Infection)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NPO Petrovax</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NPO Petrovax</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and&#xD;
      sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute&#xD;
      respiratory viral infections. This is a multicenter prospective, randomized, double-blind,&#xD;
      placebo-controlled, parallel-group phase 3 study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter prospective, randomized, double-blind, placebo-controlled,&#xD;
      parallel-group phase 3 study to evaluate efficacy of Polyoxidonium spray 6 mg/ml on acute&#xD;
      respiratory viral infections symptoms in children population. A study will last for 13 days&#xD;
      (maximum) for each participant and will include 6 visits: Day 0 (Screening), Day 1, Day 3,&#xD;
      Day 5, Day 8 ±1, Day 12 ±1. Express tests will be performed at the screening visit to exclude&#xD;
      subjects with influenza or streptococcal infection. All eligible subjects will be treated&#xD;
      with Polyoxidonium spray 6 mg/ml or placebo spray for 7 days. Clinical blood and urine tests&#xD;
      will be performed at days 0 and 8 ±1. Symptom Assessment Scale (SAS) will be filled in at&#xD;
      days 0, 1, 3, 5 and 8 ±1. Integrative Medicine Outcome Scale (IMOS) will be filled in by&#xD;
      investigator and a parent/adopter at day 8 ±1. Adverse events information will be collected&#xD;
      at days 1, 3, 8 ±1 and 12 ±1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">February 26, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)</measure>
    <time_frame>Day 8±1</time_frame>
    <description>Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)</measure>
    <time_frame>Day 3</time_frame>
    <description>A total number of patients (NP) without symptoms due to &quot;General intoxication symptoms&quot; domain of the Symptom Assessment Scale (SAS) was evaluated.&#xD;
A total number of patients (NP) with mild symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (1 point according SAS) was evaluated.&#xD;
A total number of patients (NP) with moderate symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (2 point according SAS) was be evaluated.&#xD;
A total number of patients (NP) with severe symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (3 point according SAS) was evaluated.&#xD;
Domain &quot;General intoxication symptoms&quot; includes the following symptoms:&#xD;
altered/decreased activity;&#xD;
altered appetite;&#xD;
unhealthy appearance;&#xD;
altered or interrupted sleep.&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment</measure>
    <time_frame>Day 3, Day 5</time_frame>
    <description>Each symptom was graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment</measure>
    <time_frame>Day 3, Day 5</time_frame>
    <description>Each symptom was graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment</measure>
    <time_frame>Day 3, Day 5</time_frame>
    <description>Symptom Assessment Scale (SAS) consists of 3 domains:&#xD;
Domain &quot;General intoxication symptoms&quot; (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);&#xD;
&quot;Nose symptoms&quot; (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);&#xD;
&quot;Throat and thoracic symptoms&quot; (hoarseness; sore throat; cough).&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator</measure>
    <time_frame>Day 8±1</time_frame>
    <description>Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:&#xD;
0 points - absolute recovery;&#xD;
point - significant improvement;&#xD;
points - slight to moderate improvement;&#xD;
points - unchanged;&#xD;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter</measure>
    <time_frame>Day 8±1</time_frame>
    <description>Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:&#xD;
0 points - absolute recovery;&#xD;
point - significant improvement;&#xD;
points - slight to moderate improvement;&#xD;
points - unchanged;&#xD;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cases of Antifebrile Agents Use</measure>
    <time_frame>Day 8±1</time_frame>
    <description>Number of cases of the antipyretic product (paracetamol) consumption for the entire study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy</measure>
    <time_frame>Day 8±1</time_frame>
    <description>Number of patients who discontinued from the study due to requirement for antibacterial therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Normalization of Body Temperature by 5 Day of Treatment</measure>
    <time_frame>Day 5</time_frame>
    <description>Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment</measure>
    <time_frame>Day 5</time_frame>
    <description>Symptom Assessment Scale (SAS) consists of 3 domains:&#xD;
Domain &quot;General intoxication symptoms&quot; (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);&#xD;
&quot;Nose symptoms&quot; (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);&#xD;
&quot;Throat and thoracic symptoms&quot; (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Polyoxidonium 6 mg/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, nasal and sublingual spray - 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyoxidonium 6 mg/ml</intervention_name>
    <description>Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
    <arm_group_label>Polyoxidonium 6 mg/ml</arm_group_label>
    <other_name>Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo, Nasal and Sublingual Spray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 1 to 12 years&#xD;
&#xD;
          -  Diagnosis of acute respiratory viral infection [International Classification of&#xD;
             Diseases (10-th revision) codes: Acute nasopharyngitis [common cold], J02 Acute&#xD;
             pharyngitis, J02.9 Acute pharyngitis, unspecified, J04 Acute laryngitis and&#xD;
             tracheitis, J04.0 Acute laryngitis, J04.1 Acute tracheitis, J04.2 Acute&#xD;
             laryngotracheitis, J06 Acute upper respiratory infections of multiple and unspecified&#xD;
             sites, J06.0 Acute laryngopharyngitis, J06.9 Acute upper respiratory infection,&#xD;
             unspecified] confirmed by physical examination: axillary temperature ≥ 37,0°C&#xD;
             (measured at the moment of physical examination) and Symptoms Assessment Scale total&#xD;
             score ≥5 points (not less than 3 of which should be related to ear, or nose, or&#xD;
             throat, or upper respiratory tract affection symptoms).&#xD;
&#xD;
          -  Less than 24 hours from the onset of disease (first respiratory viral infection&#xD;
             symptoms)&#xD;
&#xD;
          -  Informed consent signed by parent/adopter, or a child (applicable for children aged &gt;&#xD;
             10 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspicion on pneumonia, bacterial infection (including meningitis, sepsis, otitis&#xD;
             media, sinusitis, sinusitis, urinary tract infection etc.) or a condition that&#xD;
             requires antibacterial therapy from the first day of treatment.&#xD;
&#xD;
          -  Suspicion on other diseases that may simulate acute respiratory viral infection at the&#xD;
             moment of onset (other infectious diseases, flu-like syndrome in system collagen and&#xD;
             other diseases).&#xD;
&#xD;
          -  Positive express test for influenza or streptococcal infection.&#xD;
&#xD;
          -  Clinical signs of serious acute respiratory viral infection, which requires&#xD;
             hospitalization (fever ≥ 40°C, sings of airway obstruction, significant hemodynamic or&#xD;
             neurological disorders).&#xD;
&#xD;
          -  History of primary or secondary immunodeficiency.&#xD;
&#xD;
          -  Cancer.&#xD;
&#xD;
          -  Acute infectious and non-infectious diseases (except acute respiratory viral&#xD;
             infection), exacerbation or decompensation of chronic diseases (diabetes mellitus,&#xD;
             infantile cerebral paralysis, cystic fibrosis, primary ciliary dyskinesia,&#xD;
             bronchopulmonary dysplasia, malformations of upper respiratory tract,ears, nose, or&#xD;
             throat) which may affect an ability of patient to participate in study.&#xD;
&#xD;
          -  Saccharase/isomaltase deficiency, fructose intolerance, glucose-galactose&#xD;
             malabsorption.&#xD;
&#xD;
          -  History of allergy/hypersensitivity to any component of the study drug (including&#xD;
             paracetamol, propacetamol hydrochloride).&#xD;
&#xD;
          -  Use of protocol-prohibited medications within 1 month prior to study.&#xD;
&#xD;
          -  Children, who's parents/adopters may fail to follow the protocol procedures and&#xD;
             treatment, in investigator's opinion.&#xD;
&#xD;
          -  Participation in other studies within 3 months to screening.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Any other medical or social condition that may interrupt study participation, in&#xD;
             investigator's opinion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikolai Dodonov</last_name>
    <role>Study Chair</role>
    <affiliation>NPO Petrovax</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Center &quot;Medical Technology&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Leningrad Region</state>
        <zip>192148</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;MedAestheticCentre Laboratory&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Leningrad Region</state>
        <zip>192177</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center &quot;Curator&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Leningrad Region</state>
        <zip>196240</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's City Hospital No. 22</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Leningrad Region</state>
        <zip>196657</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center &quot;Korolev Medicine&quot;</name>
      <address>
        <city>Naro-Fominsk</city>
        <state>Moscow Region</state>
        <zip>143300</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Children's Clinical Clinic №5</name>
      <address>
        <city>Perm'</city>
        <state>Perm Region</state>
        <zip>614066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's City Clinic №4 of the city of Rostov-on-Don</name>
      <address>
        <city>Rostov-on-Don</city>
        <state>Rostov Region</state>
        <zip>344065</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl State Medical University</name>
      <address>
        <city>Yaroslavl</city>
        <state>Yaroslavl Region</state>
        <zip>150000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Children's Clinical Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <state>Yaroslavl Region</state>
        <zip>150042</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal state budgetary institution &quot;Research Institute of Influenza&quot; of Ministry of Health of Russia</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <results_reference>
    <citation>Garashchenko TI, Karneeva OV, Tarasova GT, Kim IA, Hanferian RA (2020) Efficacy and safety of azoximer bromide (Polyoxidonium) in children aged from 1 to 12 years with ARI: The results of a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group study. Pediatr Dimensions 5: DOI: 10.15761/PD.1000204.</citation>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>June 5, 2020</results_first_submitted>
  <results_first_submitted_qc>June 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2020</results_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ARI, acute respiratory infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03840135/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Polyoxidonium 6 mg/ml</title>
          <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>172 patients were randomized, 8 people dropped out during the trial (due to protocol violations and withdrawal of informed consent). 164 patients completed the study, data from 155 children were accepted for the final analysis (9 patients were excluded from the analysis due to protocol violations).</population>
      <group_list>
        <group group_id="B1">
          <title>Polyoxidonium 6 mg/ml</title>
          <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="76"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="155"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" lower_limit="2" upper_limit="8"/>
                    <measurement group_id="B2" value="5" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="B3" value="5" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass</title>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.85" lower_limit="14.6" upper_limit="30"/>
                    <measurement group_id="B2" value="18" lower_limit="15" upper_limit="27"/>
                    <measurement group_id="B3" value="19" lower_limit="14.5" upper_limit="28.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body height</title>
          <units>m</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.16" lower_limit="0.96" upper_limit="1.33"/>
                    <measurement group_id="B2" value="1.12" lower_limit="0.98" upper_limit="1.29"/>
                    <measurement group_id="B3" value="1.13" lower_limit="0.97" upper_limit="1.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)</title>
        <description>Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever</description>
        <time_frame>Day 8±1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)</title>
          <description>Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever</description>
          <units>day</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.04" lower_limit="1.74" upper_limit="2.34"/>
                    <measurement group_id="O2" value="2.26" lower_limit="2.03" upper_limit="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)</title>
        <description>A total number of patients (NP) without symptoms due to &quot;General intoxication symptoms&quot; domain of the Symptom Assessment Scale (SAS) was evaluated.&#xD;
A total number of patients (NP) with mild symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (1 point according SAS) was evaluated.&#xD;
A total number of patients (NP) with moderate symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (2 point according SAS) was be evaluated.&#xD;
A total number of patients (NP) with severe symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (3 point according SAS) was evaluated.&#xD;
Domain &quot;General intoxication symptoms&quot; includes the following symptoms:&#xD;
altered/decreased activity;&#xD;
altered appetite;&#xD;
unhealthy appearance;&#xD;
altered or interrupted sleep.&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe.</description>
        <time_frame>Day 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)</title>
          <description>A total number of patients (NP) without symptoms due to &quot;General intoxication symptoms&quot; domain of the Symptom Assessment Scale (SAS) was evaluated.&#xD;
A total number of patients (NP) with mild symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (1 point according SAS) was evaluated.&#xD;
A total number of patients (NP) with moderate symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (2 point according SAS) was be evaluated.&#xD;
A total number of patients (NP) with severe symptoms due to &quot;General intoxication symptoms&quot; domain of SAS (3 point according SAS) was evaluated.&#xD;
Domain &quot;General intoxication symptoms&quot; includes the following symptoms:&#xD;
altered/decreased activity;&#xD;
altered appetite;&#xD;
unhealthy appearance;&#xD;
altered or interrupted sleep.&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NP without altered/decreased activity day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild altered/decreased activity day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate altered/decreased activity day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe altered/decreased activity day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without altered/decreased activity day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild altered/decreased activity day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate altered/decreased activity day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe altered/decreased activity day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without altered appetite day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild altered appetite day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate altered appetite day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe altered appetite day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without altered appetite day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild altered appetite day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate altered appetite day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe altered appetite day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without unhealthy appearance day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild unhealthy appearance day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate unhealthy appearance day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe mild unhealthy appearance day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without unhealthy appearance day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild unhealthy appearance day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate unhealthy appearance day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe unhealthy appearance day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without altered or interrupted sleep day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild altered or interrupted sleep day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate altered or interrupt. sleep day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe altered or interrupt. sleep day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP without altered or interrupted sleep day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with mild altered or interrupted sleep day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with moderate altered or interrupt. sleep day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NP with severe altered or interrupt. sleep day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>χ2 Pearson criterion</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment</title>
        <description>Each symptom was graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)</description>
        <time_frame>Day 3, Day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment</title>
          <description>Each symptom was graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <title>NP without nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with mild nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with moderate nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with severe nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <title>NP without nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with mild nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with moderate nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with severe nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <title>NP without nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with mild nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with moderate nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NP with severe nasal discharge symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>χ2 Pearson criterion</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment</title>
        <description>Each symptom was graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.</description>
        <time_frame>Day 3, Day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment</title>
          <description>Each symptom was graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>nasal discharge day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nasal discharge by day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nasal discharge by day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nasal congestion/impaired nasal airflow by day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="2"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nasal congestion/impaired nasal airflow by day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nasal congestion/impaired nasal airflow by day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>χ2 Pearson criterion</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment</title>
        <description>Symptom Assessment Scale (SAS) consists of 3 domains:&#xD;
Domain &quot;General intoxication symptoms&quot; (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);&#xD;
&quot;Nose symptoms&quot; (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);&#xD;
&quot;Throat and thoracic symptoms&quot; (hoarseness; sore throat; cough).&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.</description>
        <time_frame>Day 3, Day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment</title>
          <description>Symptom Assessment Scale (SAS) consists of 3 domains:&#xD;
Domain &quot;General intoxication symptoms&quot; (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);&#xD;
&quot;Nose symptoms&quot; (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);&#xD;
&quot;Throat and thoracic symptoms&quot; (hoarseness; sore throat; cough).&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="8" upper_limit="14"/>
                    <measurement group_id="O2" value="10" lower_limit="8" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="2.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="5.00" lower_limit="3.00" upper_limit="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="3.00" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator</title>
        <description>Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:&#xD;
0 points - absolute recovery;&#xD;
point - significant improvement;&#xD;
points - slight to moderate improvement;&#xD;
points - unchanged;&#xD;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.</description>
        <time_frame>Day 8±1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator</title>
          <description>Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:&#xD;
0 points - absolute recovery;&#xD;
point - significant improvement;&#xD;
points - slight to moderate improvement;&#xD;
points - unchanged;&#xD;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>absolute recovery</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>significant improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>slight to moderate improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>unchanged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>decline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>χ2 Pearson criterion</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter</title>
        <description>Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:&#xD;
0 points - absolute recovery;&#xD;
point - significant improvement;&#xD;
points - slight to moderate improvement;&#xD;
points - unchanged;&#xD;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.</description>
        <time_frame>Day 8±1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter</title>
          <description>Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:&#xD;
0 points - absolute recovery;&#xD;
point - significant improvement;&#xD;
points - slight to moderate improvement;&#xD;
points - unchanged;&#xD;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>absolute recovery</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>significant improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>slight to moderate improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>unchanged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>decline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>χ2 Pearson criterion</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cases of Antifebrile Agents Use</title>
        <description>Number of cases of the antipyretic product (paracetamol) consumption for the entire study period</description>
        <time_frame>Day 8±1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cases of Antifebrile Agents Use</title>
          <description>Number of cases of the antipyretic product (paracetamol) consumption for the entire study period</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy</title>
        <description>Number of patients who discontinued from the study due to requirement for antibacterial therapy</description>
        <time_frame>Day 8±1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy</title>
          <description>Number of patients who discontinued from the study due to requirement for antibacterial therapy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Normalization of Body Temperature by 5 Day of Treatment</title>
        <description>Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature</description>
        <time_frame>Day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Normalization of Body Temperature by 5 Day of Treatment</title>
          <description>Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment</title>
        <description>Symptom Assessment Scale (SAS) consists of 3 domains:&#xD;
Domain &quot;General intoxication symptoms&quot; (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);&#xD;
&quot;Nose symptoms&quot; (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);&#xD;
&quot;Throat and thoracic symptoms&quot; (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe.</description>
        <time_frame>Day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyoxidonium 6 mg/ml</title>
            <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment</title>
          <description>Symptom Assessment Scale (SAS) consists of 3 domains:&#xD;
Domain &quot;General intoxication symptoms&quot; (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);&#xD;
&quot;Nose symptoms&quot; (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);&#xD;
&quot;Throat and thoracic symptoms&quot; (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.&#xD;
Each symptom may be graded by the following points:&#xD;
0 points - absent;&#xD;
1 point - mild;&#xD;
2 points - moderate;&#xD;
3 points - severe.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12±1 days</time_frame>
      <desc>Among 172 randomized patients, 2 patients did not take the study drug for reasons of non-compliance with inclusion criterion No. 3 and withdrawal of informed consent, respectively. Thus, the safety analysis included data from 170 patients (84 in the study drug group and 86 in the comparison drug group) who were included in the study and took the drug at least once.</desc>
      <group_list>
        <group group_id="E1">
          <title>Polyoxidonium 6 mg/ml</title>
          <description>Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.&#xD;
Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo, nasal and sublingual spray - 7 days.&#xD;
Placebo: Placebo nasal and sublingual spray will be administered for 7 days:&#xD;
in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>acute catarrhal otitis media on the left</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>acute purulent otitis media on the left</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>acute otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>loose stool</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>nose bleed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nikolay Dodonov, Head of medical department</name_or_title>
      <organization>NPO Petrovax Pharm, LLC</organization>
      <phone>+7(495) 730-75-45 ext 125</phone>
      <email>DodonovNS@petrovax.ru</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840135
org study id: PoArvi/PhIII_2017
nct id: NCT03840135
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and
      sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute
      respiratory viral infections. This is a multicenter prospective, randomized, double-blind,
      placebo-controlled, parallel-group phase 3 study.
This is a multicenter prospective, randomized, double-blind, placebo-controlled,
      parallel-group phase 3 study to evaluate efficacy of Polyoxidonium spray 6 mg/ml on acute
      respiratory viral infections symptoms in children population. A study will last for 13 days
      (maximum) for each participant and will include 6 visits: Day 0 (Screening), Day 1, Day 3,
      Day 5, Day 8 ±1, Day 12 ±1. Express tests will be performed at the screening visit to exclude
      subjects with influenza or streptococcal infection. All eligible subjects will be treated
      with Polyoxidonium spray 6 mg/ml or placebo spray for 7 days. Clinical blood and urine tests
      will be performed at days 0 and 8 ±1. Symptom Assessment Scale (SAS) will be filled in at
      days 0, 1, 3, 5 and 8 ±1. Integrative Medicine Outcome Scale (IMOS) will be filled in by
      investigator and a parent/adopter at day 8 ±1. Adverse events information will be collected
      at days 1, 3, 8 ±1 and 12 ±1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)
time frame: Day 8±1
description: Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever
measure: Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)
time frame: Day 3
description: A total number of patients (NP) without symptoms due to "General intoxication symptoms" domain of the Symptom Assessment Scale (SAS) was evaluated.
A total number of patients (NP) with mild symptoms due to "General intoxication symptoms" domain of SAS (1 point according SAS) was evaluated.
A total number of patients (NP) with moderate symptoms due to "General intoxication symptoms" domain of SAS (2 point according SAS) was be evaluated.
A total number of patients (NP) with severe symptoms due to "General intoxication symptoms" domain of SAS (3 point according SAS) was evaluated.
Domain "General intoxication symptoms" includes the following symptoms:
altered/decreased activity;
altered appetite;
unhealthy appearance;
altered or interrupted sleep.
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe.
measure: Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment
time frame: Day 3, Day 5
description: Each symptom was graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)
measure: Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment
time frame: Day 3, Day 5
description: Each symptom was graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.
measure: Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment
time frame: Day 3, Day 5
description: Symptom Assessment Scale (SAS) consists of 3 domains:
Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
"Nose symptoms" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);
"Throat and thoracic symptoms" (hoarseness; sore throat; cough).
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
measure: Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator
time frame: Day 8±1
description: Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:
0 points - absolute recovery;
point - significant improvement;
points - slight to moderate improvement;
points - unchanged;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
measure: Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter
time frame: Day 8±1
description: Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition:
0 points - absolute recovery;
point - significant improvement;
points - slight to moderate improvement;
points - unchanged;
points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
measure: Number of Cases of Antifebrile Agents Use
time frame: Day 8±1
description: Number of cases of the antipyretic product (paracetamol) consumption for the entire study period
measure: Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy
time frame: Day 8±1
description: Number of patients who discontinued from the study due to requirement for antibacterial therapy
measure: Number of Patients With Normalization of Body Temperature by 5 Day of Treatment
time frame: Day 5
description: Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature
measure: Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment
time frame: Day 5
description: Symptom Assessment Scale (SAS) consists of 3 domains:
Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
"Nose symptoms" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);
"Throat and thoracic symptoms" (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
Each symptom may be graded by the following points:
0 points - absent;
1 point - mild;
2 points - moderate;
3 points - severe.
arm group label: Polyoxidonium 6 mg/ml
arm group type: Experimental
description: Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, nasal and sublingual spray - 7 days.
intervention type: Drug
intervention name: Polyoxidonium 6 mg/ml
description: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).
arm group label: Polyoxidonium 6 mg/ml
other name: Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml
intervention type: Other
intervention name: Placebo
description: Placebo nasal and sublingual spray will be administered for 7 days:
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).
arm group label: Placebo
other name: Placebo, Nasal and Sublingual Spray
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
last name: Nikolai Dodonov
role: Study Chair
affiliation: NPO Petrovax
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country: Russian Federation
citation: Garashchenko TI, Karneeva OV, Tarasova GT, Kim IA, Hanferian RA (2020) Efficacy and safety of azoximer bromide (Polyoxidonium) in children aged from 1 to 12 years with ARI: The results of a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group study. Pediatr Dimensions 5: DOI: 10.15761/PD.1000204.
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Tract Infections
sharing ipd: No
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outcome list: 
reported events: 
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