<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/NCT04413929</url>
  </required_header>
  <id_info>
    <org_study_id>HERMITAGE</org_study_id>
    <nct_id>NCT04413929</nct_id>
  </id_info>
  <brief_title>Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.</brief_title>
  <acronym>HERMITAGE</acronym>
  <official_title>International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Materia Medica Holding</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Materia Medica Holding</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The observational study to get the additional data of the safety and effectiveness of&#xD;
      Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observational study is aimed to provide additional safety and effectiveness data for&#xD;
      Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients, including&#xD;
      cases with delayed treatment initiation of illness, and in allergy patients. Routine clinical&#xD;
      practice in the management of outpatients with ARVI is to be studied in Azerbaijan, Armenia,&#xD;
      Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan and Uzbekistan: the demographic&#xD;
      characteristics of patients, duration and time points of treatment with the use of Ergoferon,&#xD;
      its safety, and the frequency of additional medication.&#xD;
&#xD;
      Scope of the study: 519 general practitioners; 8411 patients. Physical examinations and tests&#xD;
      are performed according to local outpatient clinical practice, and to local and international&#xD;
      medical care standards.&#xD;
&#xD;
      Data to be collected and analyzed after the completion of treatment:&#xD;
&#xD;
        -  demographics (age, gender, and city/town of residence)&#xD;
&#xD;
        -  severity of illness (mild, moderate, or severe)&#xD;
&#xD;
        -  comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD),&#xD;
           chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema,&#xD;
           asthma, or other)&#xD;
&#xD;
        -  the time of resolution of infection symptoms (absence of fever - a body temperature&#xD;
           below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of&#xD;
           appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore&#xD;
           throat, or other), and other symptoms&#xD;
&#xD;
        -  illness time points: onset of illness, first visit to the doctor's office, and start of&#xD;
           treatment.&#xD;
&#xD;
        -  symptomatic therapy (drug name, date prescribed, and date discontinued)&#xD;
&#xD;
        -  therapy for bacterial complications (date the antimicrobial drug is prescribed, drug&#xD;
           name, diagnosis, hospitalization or no hospitalization required, date of&#xD;
           hospitalization)&#xD;
&#xD;
        -  serious adverse events (description of the event, causality (related/ not related to&#xD;
           Ergoferon), severity, date of the onset, and actions taken)&#xD;
&#xD;
        -  efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory:&#xD;
           improvement/ insufficient: no effect) - observational study model: cohort Cohort study&#xD;
           is an observation of outcomes in a group of individuals linked by shared characteristics&#xD;
           (an acute respiratory viral infections and use of Ergoferon).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Influenza/ARVI Symptoms.</measure>
    <time_frame>through study completion up to 1 month</time_frame>
    <description>The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Increased Body Temperature.</measure>
    <time_frame>through study completion up to 1 month</time_frame>
    <description>A body temperature ≥37.0 °С. Based on Case Report Form data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Systemic Symptoms.</measure>
    <time_frame>through study completion up to 1 month</time_frame>
    <description>Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).&#xD;
Based on Case Report Form data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Nose Symptoms.</measure>
    <time_frame>through study completion up to 1 month</time_frame>
    <description>Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Throat Symptoms.</measure>
    <time_frame>through study completion up to 1 month</time_frame>
    <description>Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Complications of Influenza/Acute Viral URI.</measure>
    <time_frame>through study completion up to 1 month</time_frame>
    <description>Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8411</enrollment>
  <condition>Viral Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Ergoferon</arm_group_label>
    <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ergoferon</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>Ergoferon</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children from 6 months to 18 years of age and adults over 18 years of age in any gender and&#xD;
        demographic proportion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Data of children from 6 months to 18 years old and adults over 18 years old.&#xD;
&#xD;
          -  Diagnosis: Flu / ARVI.&#xD;
&#xD;
          -  Axillary temperature above 37.4 °С.&#xD;
&#xD;
          -  At least one systemic and/or catarrhal symptom lasting 12 hours to 3 days by the time&#xD;
             the doctor is consulted, for which treatment with Ergoferon is prescribed.&#xD;
&#xD;
          -  A specific decision of the doctor to prescribe Ergoferon in strict accordance with the&#xD;
             indications, regardless of the factor of including patient data in the program.&#xD;
&#xD;
          -  CRF, filled by a doctor on the basis of medical documentation, at the end of patient&#xD;
             observation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not applicable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <results_first_submitted>January 19, 2021</results_first_submitted>
  <results_first_submitted_qc>March 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 2, 2021</results_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 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>Respiratory Tract Infections</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>September 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04413929/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>Oral administration in the therapeutic dosage specified in the instructions for medical use: 8 tablets on the first day of treatment (1 tablet every 30 minutes during the first 2 hours, then 3 more tablet intakes with regular intervals in between);from the second day until recovery take 1 tablet 3 times a day. The duration of the reception was regulated by the physician.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8411"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8411"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ergoferon</title>
          <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8411"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Children (age under 18) and adults presented separately. A number of patients did not reported their age (N=337)</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>All included patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8074"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.43" spread="15.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adults</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2069"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.75" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6005"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.75" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>A number of patients (N=220) did not reported their sex</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="8191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4220"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3971"/>
                  </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_list>
                </analyzed>
              </analyzed_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="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2718"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uzbekistan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Azerbaijan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Armenia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kyrgyzstan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mongolia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tajikistan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Influenza/ARVI Symptoms.</title>
        <description>The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.</description>
        <time_frame>through study completion up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.&#xD;
Ergoferon: Oral administration</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Influenza/ARVI Symptoms.</title>
          <description>The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Increased Body Temperature.</title>
        <description>A body temperature ≥37.0 °С. Based on Case Report Form data.</description>
        <time_frame>through study completion up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Increased Body Temperature.</title>
          <description>A body temperature ≥37.0 °С. Based on Case Report Form data.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.99" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Systemic Symptoms.</title>
        <description>Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).&#xD;
Based on Case Report Form data.</description>
        <time_frame>through study completion up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Systemic Symptoms.</title>
          <description>Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).&#xD;
Based on Case Report Form data.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Nose Symptoms.</title>
        <description>Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.</description>
        <time_frame>through study completion up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Nose Symptoms.</title>
          <description>Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Throat Symptoms.</title>
        <description>Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.</description>
        <time_frame>through study completion up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Throat Symptoms.</title>
          <description>Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Complications of Influenza/Acute Viral URI.</title>
        <description>Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.</description>
        <time_frame>through study completion up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ergoferon</title>
            <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Complications of Influenza/Acute Viral URI.</title>
          <description>Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation 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="8411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 6 months</time_frame>
      <desc>The collection of information was carried out in accordance with the legislation of the participating countries for spontaneous reports of AEs within the framework of the existing practice of ARVI management, monitoring of medical researchers was not carried out due to the non-interventional nature of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ergoferon</title>
          <description>Oral administration in the therapeutic dosage specified in the instructions for medical use.&#xD;
Ergoferon: Oral administration in the therapeutic dosage specified in the instructions for medical use.</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="8411"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8411"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8411"/>
              </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>Mikhail 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/NCT04413929
org study id: HERMITAGE
nct id: NCT04413929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The observational study to get the additional data of the safety and effectiveness of
      Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.
This observational study is aimed to provide additional safety and effectiveness data for
      Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients, including
      cases with delayed treatment initiation of illness, and in allergy patients. Routine clinical
      practice in the management of outpatients with ARVI is to be studied in Azerbaijan, Armenia,
      Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan and Uzbekistan: the demographic
      characteristics of patients, duration and time points of treatment with the use of Ergoferon,
      its safety, and the frequency of additional medication.

      Scope of the study: 519 general practitioners; 8411 patients. Physical examinations and tests
      are performed according to local outpatient clinical practice, and to local and international
      medical care standards.

      Data to be collected and analyzed after the completion of treatment:

        -  demographics (age, gender, and city/town of residence)

        -  severity of illness (mild, moderate, or severe)

        -  comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD),
           chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema,
           asthma, or other)

        -  the time of resolution of infection symptoms (absence of fever - a body temperature
           below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of
           appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore
           throat, or other), and other symptoms

        -  illness time points: onset of illness, first visit to the doctor's office, and start of
           treatment.

        -  symptomatic therapy (drug name, date prescribed, and date discontinued)

        -  therapy for bacterial complications (date the antimicrobial drug is prescribed, drug
           name, diagnosis, hospitalization or no hospitalization required, date of
           hospitalization)

        -  serious adverse events (description of the event, causality (related/ not related to
           Ergoferon), severity, date of the onset, and actions taken)

        -  efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory:
           improvement/ insufficient: no effect) - observational study model: cohort Cohort study
           is an observation of outcomes in a group of individuals linked by shared characteristics
           (an acute respiratory viral infections and use of Ergoferon).
observational model: Cohort
time perspective: Retrospective
measure: Duration of Influenza/ARVI Symptoms.
time frame: through study completion up to 1 month
description: The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.
measure: Duration of Increased Body Temperature.
time frame: through study completion up to 1 month
description: A body temperature ≥37.0 °С. Based on Case Report Form data.
measure: Duration of Systemic Symptoms.
time frame: through study completion up to 1 month
description: Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).
Based on Case Report Form data.
measure: Duration of Nose Symptoms.
time frame: through study completion up to 1 month
description: Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.
measure: Duration of Throat Symptoms.
time frame: through study completion up to 1 month
description: Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.
measure: Percentage of Patients With Complications of Influenza/Acute Viral URI.
time frame: through study completion up to 1 month
description: Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.
arm group label: Ergoferon
description: Oral administration in the therapeutic dosage specified in the instructions for medical use.
intervention type: Drug
intervention name: Ergoferon
description: Oral administration
arm group label: Ergoferon
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Tract Infections
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 