<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/NCT04400058</url>
  </required_header>
  <id_info>
    <org_study_id>GAM10-10</org_study_id>
    <nct_id>NCT04400058</nct_id>
  </id_info>
  <brief_title>Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression</brief_title>
  <official_title>Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Octapharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Octapharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to&#xD;
      evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in&#xD;
      patients with severe Coronavirus disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stabilization or Improvement in Clinical Status</measure>
    <time_frame>7 days</time_frame>
    <description>Proportion of subjects with stabilized or improved clinical status at Day 7 on at least one category on a 6-point clinical status scale.&#xD;
Clinical status categories will be defined as:&#xD;
Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).&#xD;
Hospitalization, not requiring supplemental oxygen.&#xD;
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).&#xD;
ICU/hospitalization, requiring NIV/HFNC therapy.&#xD;
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.&#xD;
Death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive Clinical Status Analysis</measure>
    <time_frame>7 days</time_frame>
    <description>Change from Baseline (Day 1) at Day 7 in terms of the 6-point clinical status scale (descriptive analysis).&#xD;
Clinical status categories will be defined as:&#xD;
Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).&#xD;
Hospitalization, not requiring supplemental oxygen.&#xD;
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).&#xD;
ICU/hospitalization, requiring NIV/HFNC therapy.&#xD;
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.&#xD;
Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Status Assessment</measure>
    <time_frame>14 days</time_frame>
    <description>Proportion of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. (This endpoint will go into formal hypothesis testing procedure)&#xD;
Clinical status categories will be defined as:&#xD;
Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).&#xD;
Hospitalization, not requiring supplemental oxygen.&#xD;
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).&#xD;
ICU/hospitalization, requiring NIV/HFNC therapy.&#xD;
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.&#xD;
Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to death</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Time to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical Ventilation Initiation</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Proportion of subjects requiring invasive mechanical ventilation by Day 33.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical Ventilation Duration</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Duration of invasive mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SARS-CoV-2 Test Result</measure>
    <time_frame>7 days</time_frame>
    <description>Results of RT-PCR for SARS-CoV-2 from nares/throat swab and/or sputum and/or lower respiratory tract sample on Day 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of all AEs</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Incidence of all AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs considered related to the IMP</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Incidence of AEs considered related to the IMP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events (SAEs)</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Incidence of serious adverse events (SAEs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological findings (chest CT/chest X-ray)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Radiological findings (chest CT/chest X-ray)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>Up to 33 daya</time_frame>
    <description>Change from baseline in blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood calcium</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in blood calcium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in sodium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in potassium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbon dioxide</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in carbon dioxide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chloride</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in chloride</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total protein</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in total protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline phosphatase</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in alkaline phosphatase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine transaminase</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in alanine transaminase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate aminotransferase</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in aspartate aminotransferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood urea nitrogen</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in blood urea nitrogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in D-dimer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in fibrinogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PT</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in PT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTT</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in PTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INR</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in INR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hsCRP</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in hsCRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in ferritin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in LDH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgG</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in IgG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgM</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in IgM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgA</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in IgA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IFE</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in IFE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in troponin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red blood cell count</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in red blood cell count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in hemoglobjn</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in hematocrit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corpuscular volume</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in mean corpuscular volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corpuscular hemoglobin</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in mean corpuscular hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean corpuscular hemoglobin concentration</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in mean corpuscular hemoglobin concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red cell distribution width</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in red cell distribution width</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White blood cell count</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in white blood cell count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White blood cell differential</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in white blood cell differential</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet count</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in platelet count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean platelet volume</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in mean platelet volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet distribution width</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in platelet distribution width</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in SpO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A-a gradient</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in A-a gradient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in pulse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiration Rate</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in respiration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Temperature</measure>
    <time_frame>Up to 33 days</time_frame>
    <description>Change from baseline in body temperature</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Octagam 10%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Octagam 10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Octagam 10%</intervention_name>
    <description>Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days</description>
    <arm_group_label>Octagam 10%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult aged ≥18years old&#xD;
&#xD;
          2. Provide voluntary, fully informed written and signed consent before any study-related&#xD;
             procedures are conducted&#xD;
&#xD;
          3. Able to understand and comply with the relevant aspects of the study protocol&#xD;
&#xD;
          4. Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or&#xD;
             lower respiratory tract samples&#xD;
&#xD;
          5. Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio &lt;300mmHg.&#xD;
             Measurement can be taken from documented source records in the 24 hours prior to&#xD;
             screening&#xD;
&#xD;
          6. Chest imaging confirming lung involvement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Existence of other evidence that can explain pneumonia including but not limited to:&#xD;
             Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the&#xD;
             combined clinical picture, radiological findings and known laboratory results [eg,&#xD;
             elevated procalcitonin &gt;0.5ng/mL and concomitant neutrophilia]), known fungal&#xD;
             pneumonia, suspected fungal pneumonia based on compromised immune system with a&#xD;
             history of past fungal infections, noninfectious causes, etc.&#xD;
&#xD;
          2. Known history of serious allergic reactions, including anaphylaxis, to IVIG or its&#xD;
             preparation components&#xD;
&#xD;
          3. Subjects with a history of thromboembolic event (TEE) within the last 12 months, such&#xD;
             as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke,&#xD;
             transient ischemic attack, peripheral artery disease (Fontaine IV)&#xD;
&#xD;
          4. Subjects with an underlying medical condition that can lead to hypercoagulable states&#xD;
             and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C&#xD;
             deficiency, antiphospholipid syndrome and malignancy&#xD;
&#xD;
          5. Known history of selective IgA deficiency with antibodies against IgA&#xD;
&#xD;
          6. Subjects with conditions such as human immunodeficiency virus (HIV) infection, known&#xD;
             acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR&#xD;
             positive or currently treated with antivirals), pulmonary fibrosis, elevated&#xD;
             procalcitonin (&gt; 0.5) with concomitant neutrophilia (elevated polys), heparin induced&#xD;
             thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator&#xD;
             discretion based on estimated glomerular filtration rate [eGFR] &lt;59 mL/min/1.73 m2, as&#xD;
             defined by KDIGO Clinical Practice Guideline):&#xD;
&#xD;
               -  Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2&#xD;
&#xD;
               -  Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2&#xD;
&#xD;
               -  Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2&#xD;
&#xD;
               -  Kidney failure (G5): GFR &lt;15 ml/min/1.73 m2&#xD;
&#xD;
          7. Currently requiring IMV (invasive mechanical ventilation or having received IMV during&#xD;
             the last 30 days&#xD;
&#xD;
          8. Known clinically significant preexisting lung, heart, or neuromuscular disease that,&#xD;
             in the investigator's opinion, would impact subject's ability to complete study or may&#xD;
             confound the study results&#xD;
&#xD;
          9. Body weight &gt;125 kg&#xD;
&#xD;
         10. Women who are pregnant or breast-feeding&#xD;
&#xD;
         11. Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin&#xD;
             agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment&#xD;
             or plan to receive this treatment during the course of the study&#xD;
&#xD;
         12. Enrolled in other experimental interventional studies or taking experimental&#xD;
             medications (ie, convalescent plasma). Diagnostic studies can be allowed if the&#xD;
             anticipated total blood volume to be drawn across both studies and for therapeutic&#xD;
             purposes does not exceed 450 mL over any 8-week period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92357</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Midland</city>
        <state>Michigan</state>
        <zip>48670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Minot</city>
        <state>North Dakota</state>
        <zip>58701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Ivanovo</city>
        <zip>153025</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>111539</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>129301</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Ryazan'</city>
        <zip>390000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76007</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61096</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Kremenchuk</city>
        <zip>39623</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</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>COVID-19</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>gamma-Globulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Rho(D) Immune Globulin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04400058
org study id: GAM10-10
nct id: NCT04400058
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to
      evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in
      patients with severe Coronavirus disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Stabilization or Improvement in Clinical Status
time frame: 7 days
description: Proportion of subjects with stabilized or improved clinical status at Day 7 on at least one category on a 6-point clinical status scale.
Clinical status categories will be defined as:
Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).
Hospitalization, not requiring supplemental oxygen.
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
ICU/hospitalization, requiring NIV/HFNC therapy.
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
Death.
measure: Descriptive Clinical Status Analysis
time frame: 7 days
description: Change from Baseline (Day 1) at Day 7 in terms of the 6-point clinical status scale (descriptive analysis).
Clinical status categories will be defined as:
Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).
Hospitalization, not requiring supplemental oxygen.
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
ICU/hospitalization, requiring NIV/HFNC therapy.
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
Death.
measure: Clinical Status Assessment
time frame: 14 days
description: Proportion of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. (This endpoint will go into formal hypothesis testing procedure)
Clinical status categories will be defined as:
Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).
Hospitalization, not requiring supplemental oxygen.
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
ICU/hospitalization, requiring NIV/HFNC therapy.
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
Death.
measure: Time to death
time frame: Up to 33 days
description: Time to death
measure: Mechanical Ventilation Initiation
time frame: Up to 33 days
description: Proportion of subjects requiring invasive mechanical ventilation by Day 33.
measure: Mechanical Ventilation Duration
time frame: Up to 33 days
description: Duration of invasive mechanical ventilation
measure: SARS-CoV-2 Test Result
time frame: 7 days
description: Results of RT-PCR for SARS-CoV-2 from nares/throat swab and/or sputum and/or lower respiratory tract sample on Day 7.
measure: Incidence of all AEs
time frame: Up to 33 days
description: Incidence of all AEs
measure: Incidence of AEs considered related to the IMP
time frame: Up to 33 days
description: Incidence of AEs considered related to the IMP
measure: Incidence of serious adverse events (SAEs)
time frame: Up to 33 days
description: Incidence of serious adverse events (SAEs)
measure: Radiological findings (chest CT/chest X-ray)
time frame: Up to 7 days
description: Radiological findings (chest CT/chest X-ray)
measure: Blood glucose
time frame: Up to 33 daya
description: Change from baseline in blood glucose
measure: Blood calcium
time frame: Up to 33 days
description: Change from baseline in blood calcium
measure: Sodium
time frame: Up to 33 days
description: Change from baseline in sodium
measure: Potassium
time frame: Up to 33 days
description: Change from baseline in potassium
measure: Carbon dioxide
time frame: Up to 33 days
description: Change from baseline in carbon dioxide
measure: Chloride
time frame: Up to 33 days
description: Change from baseline in chloride
measure: Albumin
time frame: Up to 33 days
description: Change from baseline in albumin
measure: Total protein
time frame: Up to 33 days
description: Change from baseline in total protein
measure: Alkaline phosphatase
time frame: Up to 33 days
description: Change from baseline in alkaline phosphatase
measure: Alanine transaminase
time frame: Up to 33 days
description: Change from baseline in alanine transaminase
measure: Aspartate aminotransferase
time frame: Up to 33 days
description: Change from baseline in aspartate aminotransferase
measure: Bilirubin
time frame: Up to 33 days
description: Change from baseline in bilirubin
measure: Blood urea nitrogen
time frame: Up to 33 days
description: Change from baseline in blood urea nitrogen
measure: D-dimer
time frame: Up to 33 days
description: Change from baseline in D-dimer
measure: Fibrinogen
time frame: Up to 33 days
description: Change from baseline in fibrinogen
measure: PT
time frame: Up to 33 days
description: Change from baseline in PT
measure: PTT
time frame: Up to 33 days
description: Change from baseline in PTT
measure: INR
time frame: Up to 33 days
description: Change from baseline in INR
measure: hsCRP
time frame: Up to 33 days
description: Change from baseline in hsCRP
measure: Ferritin
time frame: Up to 33 days
description: Change from baseline in ferritin
measure: LDH
time frame: Up to 33 days
description: Change from baseline in LDH
measure: IgG
time frame: Up to 33 days
description: Change from baseline in IgG
measure: IgM
time frame: Up to 33 days
description: Change from baseline in IgM
measure: IgA
time frame: Up to 33 days
description: Change from baseline in IgA
measure: IFE
time frame: Up to 33 days
description: Change from baseline in IFE
measure: Troponin
time frame: Up to 33 days
description: Change from baseline in troponin
measure: Red blood cell count
time frame: Up to 33 days
description: Change from baseline in red blood cell count
measure: Hemoglobin
time frame: Up to 33 days
description: Change from baseline in hemoglobjn
measure: Hematocrit
time frame: Up to 33 days
description: Change from baseline in hematocrit
measure: Mean corpuscular volume
time frame: Up to 33 days
description: Change from baseline in mean corpuscular volume
measure: Mean corpuscular hemoglobin
time frame: Up to 33 days
description: Change from baseline in mean corpuscular hemoglobin
measure: Mean corpuscular hemoglobin concentration
time frame: Up to 33 days
description: Change from baseline in mean corpuscular hemoglobin concentration
measure: Red cell distribution width
time frame: Up to 33 days
description: Change from baseline in red cell distribution width
measure: White blood cell count
time frame: Up to 33 days
description: Change from baseline in white blood cell count
measure: White blood cell differential
time frame: Up to 33 days
description: Change from baseline in white blood cell differential
measure: Platelet count
time frame: Up to 33 days
description: Change from baseline in platelet count
measure: Mean platelet volume
time frame: Up to 33 days
description: Change from baseline in mean platelet volume
measure: Platelet distribution width
time frame: Up to 33 days
description: Change from baseline in platelet distribution width
measure: SpO2
time frame: Up to 33 days
description: Change from baseline in SpO2
measure: A-a gradient
time frame: Up to 33 days
description: Change from baseline in A-a gradient
measure: Blood Pressure
time frame: Up to 33 days
description: Change from baseline in blood pressure
measure: Pulse
time frame: Up to 33 days
description: Change from baseline in pulse
measure: Respiration Rate
time frame: Up to 33 days
description: Change from baseline in respiration rate
measure: Body Temperature
time frame: Up to 33 days
description: Change from baseline in body temperature
arm group label: Octagam 10%
arm group type: Experimental
description: Octagam 10%
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Biological
intervention name: Octagam 10%
description: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
arm group label: Octagam 10%
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Russian Federation
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Disease Progression
mesh term: gamma-Globulins
mesh term: Immunoglobulins, Intravenous
mesh term: Rho(D) Immune Globulin