<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/NCT03039621</url>
  </required_header>
  <id_info>
    <org_study_id>MMH-ER-009</org_study_id>
    <nct_id>NCT03039621</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children</brief_title>
  <official_title>International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Materia Medica Holding</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Materia Medica Holding</source>
  <brief_summary>
    <textblock>
      The international multicenter double-blind placebo-controlled randomized clinical study in&#xD;
      parallel groups.The objective of this study is to obtain additional data on the efficacy and&#xD;
      safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children&#xD;
      aged from 6 months to 6 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: international, multicenter double-blind placebo-controlled randomized clinical&#xD;
      study in parallel groups.&#xD;
&#xD;
      The study will enroll patients of either gender aged from 6 months to 6 years old with&#xD;
      clinical manifestations of ARVI within the first days after the onset of the disease.&#xD;
      Patients will be included evenly (1:1 ratio) in accordance with the age group: 6 months - 3&#xD;
      years 11 months 29 days; 4 years - 6 years 11 months 29 days. Signed information sheet for&#xD;
      parents/adopters (inform consent form) will be obtained from all participant's parents/&#xD;
      adopters prior to the screening procedures. Medical history, thermometry, patient examination&#xD;
      by the doctor, assesment of ARVI symptoms severity and nasopharyngeal swabswill be performed&#xD;
      at screening visit (Day 1).&#xD;
&#xD;
      If the inclusion criteria are met and exclusion criteria are absent, the patient is included&#xD;
      in the study.&#xD;
&#xD;
      Nasopharyngeal swabs will be analyzed by real-time reverse transcription polymerase chain&#xD;
      reaction (RT-PCR) to identify the most common respiratory viruses, including (1) Influenza A&#xD;
      virus; (2) Influenza B virus; (3) Influenza A (H1N1)pdm; (4) Human metapneumovirus; (5) Human&#xD;
      respiratory syncytial virus; (6) Human rhinovirus; (7) Human adenovirus; (8) Human bocavirus;&#xD;
      (9) Human parainfluenza virus 1; (10) Human parainfluenza virus 2; (11) Human parainfluenza&#xD;
      virus 3; (12) Human parainfluenza virus 4; (13) Human coronavirus OC43; (14) Human&#xD;
      coronavirus 229E; (15) Human coronavirus HKU1; (16) Human coronavirus NL63.&#xD;
&#xD;
      The patients are randomized into one of two groups: the 1st group patients will take&#xD;
      Ergoferon according to the dosage regimen for 5 days; the 2nd group patients will take&#xD;
      Placebo according to the dosage regimen of Ergoferon for 5 days. Patient's parents/ adoptive&#xD;
      parents are provided with diares, where daily in the morning and at hight they record oral&#xD;
      temperature (measured by a digital thermometer provided by Sponsor), symptoms of ARVI&#xD;
      (according to the 4-points scale), administered drug and concomitant therapy. The doctors&#xD;
      instruct parents/ adoptive parents how to fill in the diaries; the first scores of ARVI&#xD;
      symptoms severity and oral temperature are made by doctors together with the parents/adoptive&#xD;
      parents.&#xD;
&#xD;
      Patients are observed up for 14 days (screening and randomization - up to 1 day, therapy for&#xD;
      5 days, follow-up from 6 to 10 days; delayed telephone &quot;visit&quot; - on day 14).&#xD;
&#xD;
      During the observation period, two visits are planned (at home or at the medical center) on&#xD;
      day 3 (Visit 2) and day 6 (Visit 3). If patients still have any symptoms of ARVI/&#xD;
      complications of ARVI, then an additional (unscheduled) Visit 4 is provided on Day 10 of the&#xD;
      observation (at the medical center). During Visits 2, 3 (4), doctors carry out an physical&#xD;
      examination, record dynamics of ARVI symptoms and concomitant therapy, check patient's&#xD;
      diaries, which parents/adoptive parents return back at Visit 3 or 4. At Visit 3 (after 5 days&#xD;
      of therapy) compliance with the treatment is additionally assessed. A &quot;telephone visit&quot;&#xD;
      (Visit 5, Day 14 ± 1) is carried out to interview parents about the patient's condition,&#xD;
      presence/ absence of complications, and possible use of antibiotics.&#xD;
&#xD;
      During the study, symptomatic therapy and therapy for underlying chronic conditions are&#xD;
      allowed with the exception of the drugs indicated in the section &quot;Prohibited Concomitant&#xD;
      Therapy&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2016</start_date>
  <completion_date type="Actual">January 9, 2019</completion_date>
  <primary_completion_date type="Actual">January 9, 2019</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Alleviation of All ARVI Symptoms.</measure>
    <time_frame>14 days of observation.</time_frame>
    <description>Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Normalization of Body Temperature.</measure>
    <time_frame>14 days of observation.</time_frame>
    <description>Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Alleviation of Flu-like Nonspecific Symptoms.</measure>
    <time_frame>14 days of observation.</time_frame>
    <description>Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Alleviation of Respiratory Symptoms.</measure>
    <time_frame>14 days of observation.</time_frame>
    <description>Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.</measure>
    <time_frame>On days 2-6 of the observation period.</time_frame>
    <description>Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ARVI Severity.</measure>
    <time_frame>On days 2-6 of the observation period.</time_frame>
    <description>Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Recovered Patients.</measure>
    <time_frame>On days 2-6 of the observation period.</time_frame>
    <description>Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Antipyretics Use Per Patient.</measure>
    <time_frame>On days 1- 5 of the treatment period.</time_frame>
    <description>Based on patient diary data. The number of intakes of prescribed antipyretics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Worsening of Illness.</measure>
    <time_frame>14 days of observation peiod.</time_frame>
    <description>Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Acute Respiratory Viral Infections</condition>
  <arm_group>
    <arm_group_label>Ergoferon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo using Ergoferon scheme.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ergoferon</intervention_name>
    <description>For oral use.</description>
    <arm_group_label>Ergoferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>For oral use.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of both genders aged from 6 months to 6 years old.&#xD;
&#xD;
          2. ARVI based on medical examination: oral temperature of at least 38.0°C at examination&#xD;
             + total symptom severity ≥5.&#xD;
&#xD;
          3. The first 24 hours after ARVI onset.&#xD;
&#xD;
          4. Seasonal raise in ARVI incidence.&#xD;
&#xD;
          5. Availability of signed information sheet for parents/adopters(Informed Consent Form)&#xD;
             for participation in the clinical trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media,&#xD;
             urinary tract infection, etc.) requiring a prescription of antibacterial product from&#xD;
             the first day of the disease.&#xD;
&#xD;
          2. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset&#xD;
             (other infectious diseases, flu-like syndrome at the onset of systemic diseases of&#xD;
             connective tissue, oncohaematological and other diseases).&#xD;
&#xD;
          3. Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.&#xD;
&#xD;
          4. Medical history of primary and secondary immunodeficiency; oncologic conditions.&#xD;
&#xD;
          5. Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy,&#xD;
             cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations&#xD;
             of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck&#xD;
             and salivary and thyroid glands, etc.) which affect the patient's ability to&#xD;
             participate in the clinical study.&#xD;
&#xD;
          6. Malabsorption syndrome, including congenital or acquired lactase or other&#xD;
             disaccharidase deficiency, galactosemia.&#xD;
&#xD;
          7. Allergy/hypersensitivity to any components of the drug product used in the therapy.&#xD;
&#xD;
          8. Course administration of the drug products specified in the section &quot;Prohibited&#xD;
             Concomitant Therapy&quot; within two weeks prior to inclusion in the study.&#xD;
&#xD;
          9. Patients whose parents/adoptive parents will not fulfil the requirements during the&#xD;
             study or follow the order of administration of the studied drug products from the&#xD;
             investigator's point of view.&#xD;
&#xD;
         10. Participation in other clinical trials within 3 months prior to the enrollment in this&#xD;
             study.&#xD;
&#xD;
         11. The patient's parent/adoptive parent is a study specialist at the centre and is&#xD;
             directly involved in the study or is an immediate family member of the investigator.&#xD;
             Spouses parents, children or siblings, regardless of whether they are siblings or&#xD;
             adopted are considered immediate family members.&#xD;
&#xD;
         12. The patient's parent/adoptive parent works at OOO &quot;NPF &quot;MATERIA MEDICA HOLDING&quot;, i.e.&#xD;
             they are employees of the Company, temporary employees on a contract basis or&#xD;
             appointed official responsible for conduction of the study or their immediate family&#xD;
             members.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kazakh Medical Continuing Education University</name>
      <address>
        <city>Almaty</city>
        <zip>050057</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Astana Medical University</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karaganda State Medical University</name>
      <address>
        <city>Karaganda</city>
        <zip>100000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal autonomous institution &quot;Children's City Clinical Hospital №11&quot;</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Educational Institution of Higher Education &quot;Kazan Medical University&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Kazan'</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Educational Institution of Higher Education &quot;Pirogov Russian National Research Medical University&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company &quot;Diagnostics and Vaccines&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>129515</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Budgetary Health Care Institution &quot;Сity Polyclinic №44&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>192071</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Health Care Institution &quot;City Child Health Clinical Polyclinic №5&quot;</name>
      <address>
        <city>Perm'</city>
        <zip>614066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare of the Samara Region &quot;Samara City Children's Clinical Hospital named after N.N. Willow New</name>
      <address>
        <city>Samara</city>
        <zip>443079</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volgograd State Medical University</name>
      <address>
        <city>Volgograd</city>
        <zip>400131</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl State Medical University/Children's Clinic # 5</name>
      <address>
        <city>Yaroslavl'</city>
        <zip>150000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl State Medical University/Clinical Hospital # 8</name>
      <address>
        <city>Yaroslavl'</city>
        <zip>150000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>March 18, 2020</results_first_submitted>
  <results_first_submitted_qc>April 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2020</results_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 3, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03039621/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ergoferon</title>
          <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="143"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Violation of inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with protocol requirement</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Necessity to use drugs forbidden by pro</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Violation of non-inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ergoferon</title>
          <description>Ergoferon: Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo: Placebo using Ergoferon scheme.</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="143"/>
            <count group_id="B2" value="144"/>
            <count group_id="B3" value="287"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>ITT sample</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="142"/>
                    <count group_id="B3" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.3" spread="1.7"/>
                    <measurement group_id="B2" value="3.4" spread="1.7"/>
                    <measurement group_id="B3" value="3.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>ITT sample</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="142"/>
                    <count group_id="B3" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>Count of Participants</param>
          <class_list>
            <class>
              <title>Kazakhstan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="143"/>
                    <count group_id="B2" value="144"/>
                    <count group_id="B3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="143"/>
                    <count group_id="B2" value="144"/>
                    <count group_id="B3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Alleviation of All ARVI Symptoms.</title>
        <description>Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.</description>
        <time_frame>14 days of observation.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Alleviation of All ARVI Symptoms.</title>
          <description>Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.</description>
          <population>ITT sample</population>
          <units>days</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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="4.2" upper_limit="4.8"/>
                    <measurement group_id="O2" value="5.2" lower_limit="4.8" upper_limit="5.6"/>
                  </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>0.026</p_value>
            <p_value_desc>a priori threshold for statistical significance equals 0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Normalization of Body Temperature.</title>
        <description>Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).</description>
        <time_frame>14 days of observation.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Normalization of Body Temperature.</title>
          <description>Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).</description>
          <population>ITT sample</population>
          <units>days</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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.6" upper_limit="3.1"/>
                    <measurement group_id="O2" value="3.4" lower_limit="3.1" upper_limit="3.8"/>
                  </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>0.031</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Alleviation of Flu-like Nonspecific Symptoms.</title>
        <description>Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.</description>
        <time_frame>14 days of observation.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Alleviation of Flu-like Nonspecific Symptoms.</title>
          <description>Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.</description>
          <population>ITT sample</population>
          <units>days</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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.7" upper_limit="4.3"/>
                    <measurement group_id="O2" value="4.7" lower_limit="4.3" upper_limit="5.0"/>
                  </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>0.022</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Alleviation of Respiratory Symptoms.</title>
        <description>Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.</description>
        <time_frame>14 days of observation.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Alleviation of Respiratory Symptoms.</title>
          <description>Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.</description>
          <population>ITT sample</population>
          <units>days</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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="4.0" upper_limit="4.6"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.6" upper_limit="5.4"/>
                  </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>0.024</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.</title>
        <description>Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.</description>
        <time_frame>On days 2-6 of the observation period.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.</title>
          <description>Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.</description>
          <population>ITT sample</population>
          <units>score on a scale</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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="11.2" upper_limit="12.9"/>
                    <measurement group_id="O2" value="13.1" lower_limit="12.3" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="7.9" upper_limit="9.6"/>
                    <measurement group_id="O2" value="9.7" lower_limit="8.8" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="5.4" upper_limit="7.0"/>
                    <measurement group_id="O2" value="7.1" lower_limit="6.2" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="3.3" upper_limit="4.5"/>
                    <measurement group_id="O2" value="5.1" lower_limit="4.4" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.1" upper_limit="3.0"/>
                    <measurement group_id="O2" value="3.7" lower_limit="3.1" upper_limit="4.4"/>
                  </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>0.0201</p_value>
            <p_value_desc>The p-value associated with &quot;treatment&quot; factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ARVI Severity.</title>
        <description>Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.</description>
        <time_frame>On days 2-6 of the observation period.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>ARVI Severity.</title>
          <description>Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.</description>
          <population>ITT sample</population>
          <units>score on a scale*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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.6" lower_limit="36.4" upper_limit="42.8"/>
                    <measurement group_id="O2" value="44.6" lower_limit="41.2" upper_limit="48.1"/>
                  </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>0.046</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Recovered Patients.</title>
        <description>Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).</description>
        <time_frame>On days 2-6 of the observation period.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Recovered Patients.</title>
          <description>Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).</description>
          <population>ITT sample</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="98"/>
                  </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>0.0025</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.</non_inferiority_desc>
            <p_value>0.22</p_value>
            <method>Breslow-Day test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rates of Antipyretics Use Per Patient.</title>
        <description>Based on patient diary data. The number of intakes of prescribed antipyretics.</description>
        <time_frame>On days 1- 5 of the treatment period.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Antipyretics Use Per Patient.</title>
          <description>Based on patient diary data. The number of intakes of prescribed antipyretics.</description>
          <population>ITT sample</population>
          <units>number per patient</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="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.3" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.4" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.1"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.0" upper_limit="0.2"/>
                  </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>0.0037</p_value>
            <p_value_desc>The p-value associated with &quot;treatment&quot; factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Worsening of Illness.</title>
        <description>Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).</description>
        <time_frame>14 days of observation peiod.</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Worsening of Illness.</title>
          <description>Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).</description>
          <population>ITT sample</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="19"/>
                  </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>0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse/Serious adverse events were registered during 14 days (during the treatment and follow-up periods).</time_frame>
      <desc>Adverse/Serious adverse events were registered in patients of the Safety population (n=287).</desc>
      <group_list>
        <group group_id="E1">
          <title>Ergoferon</title>
          <description>1 tablet 3 times a day.&#xD;
Ergoferon: Inside, orally.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>1 tablet 3 times a day.&#xD;
Placebo: Inside, orally.</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="10" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <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="10" subjects_at_risk="143"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <description>Bilateral cervical lymphadenitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <description>Tachycardia NOS</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <description>Eyelid oedema</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <description>Diarrhoea</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Vomiting</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <description>Teething syndrome</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <description>Abdominal pain</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <description>Hyperthermia sudden</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Condition worsened</sub_title>
                <description>Condition worsened</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Adenoiditis</sub_title>
                <description>Adenoiditis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <description>Obstructive bronchitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <description>Acute gastroenteritis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <description>Acute laryngotracheitis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <description>Acute mucoid otitis media</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <description>Otitis media acute</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <description>Acute rhinitis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Adenoviral upper respiratory infection</sub_title>
                <description>Adenoviral upper respiratory infection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Gastroenterocolitis</sub_title>
                <description>Gastroenterocolitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <description>Herpes labialis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <description>Infectious mononucleosis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <description>Pharyngotonsillitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <description>Post procedural vomiting</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <description>Myalgia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <description>Muscle twitching</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Torticollis</sub_title>
                <description>Acute torticollis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <description>Nasal discharge</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <description>Cough aggravated</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <description>Dermatitis atopic aggravated</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <description>Urticaria</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Exfoliative rash</sub_title>
                <description>Rash desquamating</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <description>Localised rash</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="144"/>
              </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>Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director</name_or_title>
      <organization>Materia Medica Holding</organization>
      <phone>+74952761571 ext 302</phone>
      <email>PutilovskiyMA@materiamedica.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/NCT03039621
org study id: MMH-ER-009
nct id: NCT03039621
lead sponsor: 
The international multicenter double-blind placebo-controlled randomized clinical study in
      parallel groups.The objective of this study is to obtain additional data on the efficacy and
      safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children
      aged from 6 months to 6 years old.
Study design: international, multicenter double-blind placebo-controlled randomized clinical
      study in parallel groups.

      The study will enroll patients of either gender aged from 6 months to 6 years old with
      clinical manifestations of ARVI within the first days after the onset of the disease.
      Patients will be included evenly (1:1 ratio) in accordance with the age group: 6 months - 3
      years 11 months 29 days; 4 years - 6 years 11 months 29 days. Signed information sheet for
      parents/adopters (inform consent form) will be obtained from all participant's parents/
      adopters prior to the screening procedures. Medical history, thermometry, patient examination
      by the doctor, assesment of ARVI symptoms severity and nasopharyngeal swabswill be performed
      at screening visit (Day 1).

      If the inclusion criteria are met and exclusion criteria are absent, the patient is included
      in the study.

      Nasopharyngeal swabs will be analyzed by real-time reverse transcription polymerase chain
      reaction (RT-PCR) to identify the most common respiratory viruses, including (1) Influenza A
      virus; (2) Influenza B virus; (3) Influenza A (H1N1)pdm; (4) Human metapneumovirus; (5) Human
      respiratory syncytial virus; (6) Human rhinovirus; (7) Human adenovirus; (8) Human bocavirus;
      (9) Human parainfluenza virus 1; (10) Human parainfluenza virus 2; (11) Human parainfluenza
      virus 3; (12) Human parainfluenza virus 4; (13) Human coronavirus OC43; (14) Human
      coronavirus 229E; (15) Human coronavirus HKU1; (16) Human coronavirus NL63.

      The patients are randomized into one of two groups: the 1st group patients will take
      Ergoferon according to the dosage regimen for 5 days; the 2nd group patients will take
      Placebo according to the dosage regimen of Ergoferon for 5 days. Patient's parents/ adoptive
      parents are provided with diares, where daily in the morning and at hight they record oral
      temperature (measured by a digital thermometer provided by Sponsor), symptoms of ARVI
      (according to the 4-points scale), administered drug and concomitant therapy. The doctors
      instruct parents/ adoptive parents how to fill in the diaries; the first scores of ARVI
      symptoms severity and oral temperature are made by doctors together with the parents/adoptive
      parents.

      Patients are observed up for 14 days (screening and randomization - up to 1 day, therapy for
      5 days, follow-up from 6 to 10 days; delayed telephone "visit" - on day 14).

      During the observation period, two visits are planned (at home or at the medical center) on
      day 3 (Visit 2) and day 6 (Visit 3). If patients still have any symptoms of ARVI/
      complications of ARVI, then an additional (unscheduled) Visit 4 is provided on Day 10 of the
      observation (at the medical center). During Visits 2, 3 (4), doctors carry out an physical
      examination, record dynamics of ARVI symptoms and concomitant therapy, check patient's
      diaries, which parents/adoptive parents return back at Visit 3 or 4. At Visit 3 (after 5 days
      of therapy) compliance with the treatment is additionally assessed. A "telephone visit"
      (Visit 5, Day 14 ± 1) is carried out to interview parents about the patient's condition,
      presence/ absence of complications, and possible use of antibiotics.

      During the study, symptomatic therapy and therapy for underlying chronic conditions are
      allowed with the exception of the drugs indicated in the section "Prohibited Concomitant
      Therapy".
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to Alleviation of All ARVI Symptoms.
time frame: 14 days of observation.
description: Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
measure: Time to Normalization of Body Temperature.
time frame: 14 days of observation.
description: Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).
measure: Time to Alleviation of Flu-like Nonspecific Symptoms.
time frame: 14 days of observation.
description: Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.
measure: Time to Alleviation of Respiratory Symptoms.
time frame: 14 days of observation.
description: Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.
measure: Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.
time frame: On days 2-6 of the observation period.
description: Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
measure: ARVI Severity.
time frame: On days 2-6 of the observation period.
description: Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.
measure: Percentage of Recovered Patients.
time frame: On days 2-6 of the observation period.
description: Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).
measure: Rates of Antipyretics Use Per Patient.
time frame: On days 1- 5 of the treatment period.
description: Based on patient diary data. The number of intakes of prescribed antipyretics.
measure: Percentage of Patients With Worsening of Illness.
time frame: 14 days of observation peiod.
description: Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).
arm group label: Ergoferon
arm group type: Experimental
description: Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo using Ergoferon scheme.
intervention type: Drug
intervention name: Ergoferon
description: For oral use.
arm group label: Ergoferon
intervention type: Drug
intervention name: Placebo
description: For oral use.
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Years
healthy volunteers: No
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country: Kazakhstan
country: Russian Federation
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
provided document: 
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point of contact: 