xml: <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/NCT06009042</url>
    </required_header>
    <id_info>
      <org_study_id>PROMISE</org_study_id>
      <nct_id>NCT06009042</nct_id>
    </id_info>
    <brief_title>Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Prospective Study</brief_title>
    <official_title>Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Multicenter, Prospective, Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized study to test the efficacy of different doses of IVIG&#xD;
        (intravenous immunoglobulin) in the treatment of severe HFRS（hemorrhagic fever with renal&#xD;
        syndrome）, and provide new clinical ideas for the treatment and prognosis of HFRS patients in&#xD;
        the future.&#xD;
  &#xD;
        This study will include all hospitalized patients with confirmed severe or critically ill&#xD;
        HFRS from October 2021 to October 2023 from 9 centers.&#xD;
  &#xD;
        Participants will receive IVIG 10g/d or IVIG 20g/d. All the participants will be given&#xD;
        conventional liquid therapy and symptomatic and supportive treatment.&#xD;
  &#xD;
        Participants will be collected demographic, epidemiological history, hospitalization&#xD;
        information, clinical data, laboratory data, imaging results, treatment regimens, and&#xD;
        outcomes data.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter, prospective, randomized controlled study which aims at evaluating the&#xD;
        efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of patients&#xD;
        with severe HFRS(hemorrhagic fever with renal syndrome), and providing reference for the&#xD;
        future application of IVIG in severe hemorrhagic fever with renal syndrome. This study will&#xD;
        include approximately 100 patients with severe hemorrhagic fever with renal syndrome who are&#xD;
        randomly assigned to either the IVIG 10g/d group or the IVIG 20g/d group in a 1:1 ratio. The&#xD;
        participants in each group will receive treatments for 6 days. Both groups are given routine&#xD;
        liquid therapy and symptomatic supportive treatment. The main endpoints include&#xD;
        transformation rate, post-period rate, mortality rate, and duration of the disease. Secondary&#xD;
        endpoints include the incidence of complications and length of hospital stay.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Transformation rate</measure>
      <time_frame>up to 34th day after treatment</time_frame>
      <description>The transformation rate is defined as the rate of transformation [critical to severe, moderate or mild, severe to moderate or mild], or the rate of transition [severe to critical].</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-period rate</measure>
      <time_frame>up to 34th day after treatment</time_frame>
      <description>Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mortality rate</measure>
      <time_frame>up to 34th day after treatment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The duration of the disease</measure>
      <time_frame>up to 34th day after treatment</time_frame>
      <description>The duration of the disease is defined as the duration from symptom onset to recovery and discharge.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The incidence of complications</measure>
      <time_frame>up to 34th day after treatment</time_frame>
      <description>The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>up to 34th day after treatment</time_frame>
      <description>The length of hospital stay is defined as the number of days from admission to discharge.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>HFRS (Hemorrhagic Fever With Renal Syndrome)</condition>
    <arm_group>
      <arm_group_label>IVIG 20g/d</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IVIG 10g/d</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IVIG 20g/d</intervention_name>
      <description>The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.</description>
      <arm_group_label>IVIG 20g/d</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IVIG 10g/d</intervention_name>
      <description>The dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.</description>
      <arm_group_label>IVIG 10g/d</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The patients must meet all of the following criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years, regardless of gender;&#xD;
  &#xD;
            -  Within 5 days of onset, hospitalized patients diagnosed with epidemic hemorrhagic&#xD;
               fever (hemorrhagic fever with renal syndrome) must have at least one of the following&#xD;
               laboratory test results:&#xD;
  &#xD;
                 1. Positive for serum specific IgM(immunoglobulin M) antibodies;&#xD;
  &#xD;
                 2. Or detect hantavirus RNA(ribonucleic acid) from patient specimens;&#xD;
  &#xD;
                 3. Or the serum specific IgG(immunoglobulin G) antibody titer in the recovery phase&#xD;
                    is more than four times higher than that in the acute phase;&#xD;
  &#xD;
                 4. Or hantavirus can be isolated from patient specimens.&#xD;
  &#xD;
            -  Meet any of the following criteria:&#xD;
  &#xD;
               1. Severe illness: meet any of the following criteria: (i) Platelet count&#xD;
               20-50×10^9/L; (ii) White blood cell count 15-30×10^9/L. 2. Critical illness: meet any&#xD;
               of the following criteria: (i) Platelet count&lt;20×10^9/L; (ii) White blood cell&#xD;
               count&gt;30×10^9/L.&#xD;
  &#xD;
            -  Volunteer to join this study and be able to sign or have a written informed consent&#xD;
               form signed by a legal representative.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Exclude patients who meet any of the following criteria:&#xD;
  &#xD;
            -  Patients with primary chronic kidney disease;&#xD;
  &#xD;
            -  Patients with severe diabetes, hypertension, heart, lung, gastrointestinal tract,&#xD;
               liver, autoimmune disease or nervous system disease;&#xD;
  &#xD;
            -  Have a history of malignant tumors (including solid malignant tumors and hematological&#xD;
               malignancies etc.);&#xD;
  &#xD;
            -  Recent use of potentially nephrotoxic drugs;&#xD;
  &#xD;
            -  Pregnant or potentially pregnant patients;&#xD;
  &#xD;
            -  Patients with a history of hypersensitivity to IVIG (intravenous immunoglobulin) ;&#xD;
  &#xD;
            -  Selective IgA(immunoglobulin A) deficiency patients with IgA antibodies;&#xD;
  &#xD;
            -  Known or suspected immunodeficiency (human immunodeficiency virus infection, primary&#xD;
               immunodeficiency), use of immunosuppressive drugs (glucocorticoids);&#xD;
  &#xD;
            -  Alcoholics, drug abuse, and psychiatric patients&#xD;
  &#xD;
            -  Other conditions which researchers deem not suitable for inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qin Ning, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science &amp; Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qin Ning, Professor</last_name>
      <phone>+8613971521450</phone>
      <email>qning@vip.sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>No.1 Peoples Hospital of Guangshui</name>
        <address>
          <city>Guangshui</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qian Liu</last_name>
        <phone>13872857607</phone>
        <email>liuqian060685@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Huanggang Central Hospital</name>
        <address>
          <city>Huanggang</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Huang</last_name>
        <phone>18986552797</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Luotian County</name>
        <address>
          <city>Huanggang</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Wang</last_name>
        <phone>13409767486</phone>
        <email>196436547@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology</name>
        <address>
          <city>Macheng</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yi Zhou</last_name>
        <phone>19971181214</phone>
        <email>2513478349@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qianjiang Central Hospital</name>
        <address>
          <city>Qianjiang</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jun Wang</last_name>
        <phone>13451145526</phone>
        <email>qjn6249223@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science &amp; Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qin Ning, Professor</last_name>
        <phone>+8613971521450</phone>
        <email>qning@vip.sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xianning Central Hospital</name>
        <address>
          <city>Xianning</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jun Zhu</last_name>
        <phone>13117160652</phone>
        <email>1356266581@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Third Peoples Hospital of Yichang</name>
        <address>
          <city>Yichang</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Quan Ming</last_name>
        <phone>13872658268</phone>
        <email>737695825@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangsu Province Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Long Chuan Zhu</last_name>
        <phone>18851729930</phone>
        <email>18851729930@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Qin Ning</investigator_full_name>
      <investigator_title>Director, Department of Infectation</investigator_title>
    </responsible_party>
    <keyword>efficacy</keyword>
    <keyword>IVIG（intravenous immunoglobulin）</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhagic Fevers, Viral</mesh_term>
      <mesh_term>Hemorrhagic Fever with Renal Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fever</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunoglobulins, Intravenous</mesh_term>
      <mesh_term>gamma-Globulins</mesh_term>
      <mesh_term>Rho(D) Immune Globulin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009042
  org study id: PROMISE
  nct id: NCT06009042
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized study to test the efficacy of different doses of IVIG
        (intravenous immunoglobulin) in the treatment of severe HFRS（hemorrhagic fever with renal
        syndrome）, and provide new clinical ideas for the treatment and prognosis of HFRS patients in
        the future.
  
        This study will include all hospitalized patients with confirmed severe or critically ill
        HFRS from October 2021 to October 2023 from 9 centers.
  
        Participants will receive IVIG 10g/d or IVIG 20g/d. All the participants will be given
        conventional liquid therapy and symptomatic and supportive treatment.
  
        Participants will be collected demographic, epidemiological history, hospitalization
        information, clinical data, laboratory data, imaging results, treatment regimens, and
        outcomes data.
  This is a multicenter, prospective, randomized controlled study which aims at evaluating the
        efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of patients
        with severe HFRS(hemorrhagic fever with renal syndrome), and providing reference for the
        future application of IVIG in severe hemorrhagic fever with renal syndrome. This study will
        include approximately 100 patients with severe hemorrhagic fever with renal syndrome who are
        randomly assigned to either the IVIG 10g/d group or the IVIG 20g/d group in a 1:1 ratio. The
        participants in each group will receive treatments for 6 days. Both groups are given routine
        liquid therapy and symptomatic supportive treatment. The main endpoints include
        transformation rate, post-period rate, mortality rate, and duration of the disease. Secondary
        endpoints include the incidence of complications and length of hospital stay.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Transformation rate
  time frame: up to 34th day after treatment
  description: The transformation rate is defined as the rate of transformation [critical to severe, moderate or mild, severe to moderate or mild], or the rate of transition [severe to critical].
  measure: Post-period rate
  time frame: up to 34th day after treatment
  description: Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
  measure: Mortality rate
  time frame: up to 34th day after treatment
  measure: The duration of the disease
  time frame: up to 34th day after treatment
  description: The duration of the disease is defined as the duration from symptom onset to recovery and discharge.
  measure: The incidence of complications
  time frame: up to 34th day after treatment
  description: The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
  measure: length of hospital stay
  time frame: up to 34th day after treatment
  description: The length of hospital stay is defined as the number of days from admission to discharge.
  arm group label: IVIG 20g/d
  arm group type: Experimental
  description: Participants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.
  arm group label: IVIG 10g/d
  arm group type: Active Comparator
  description: Participants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.
  intervention type: Drug
  intervention name: IVIG 20g/d
  description: The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
  arm group label: IVIG 20g/d
  intervention type: Drug
  intervention name: IVIG 10g/d
  description: The dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
  arm group label: IVIG 10g/d
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Qin Ning, Professor
  role: Principal Investigator
  affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
  last name: Qin Ning, Professor
  phone: +8613971521450
  email: qning@vip.sina.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Qin Ning
  investigator title: Director, Department of Infectation
  mesh term: Hemorrhagic Fevers, Viral
  mesh term: Hemorrhagic Fever with Renal Syndrome
  mesh term: Syndrome
  mesh term: Fever
  mesh term: Immunoglobulins, Intravenous
  mesh term: gamma-Globulins
  mesh term: Rho(D) Immune Globulin