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The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia

Primary Purpose

2019-nCoV

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intravenous Immunoglobulin
Standard care
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 2019-nCoV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult aged >=18years old;
  • Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;
  • The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;

  • Meet any of the following criteria for severe or critical ill conditions:

    1. Respiratory rate >=30/min; or
    2. Rest SPO2<=90%; or
    3. PaO2/FiO2<=300mmHg; or
    4. Respiratory failure and needs mechanical ventilation; or
    5. Shock occurs; or
    6. Multiple organ failure and needs ICU monitoring;
  • Sign the Informed Consent Form on a voluntary basis.

Exclusion Criteria:

  • Exist of other evidences that can explain pneumonia including but not limited to:

influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;

  • Allergy to Intravenous Immunoglobulin or its preparation components;
  • Patients with selective IgA deficiency
  • Women who are pregnant or breast-feeding;
  • Researchers consider unsuitable.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    IVIG therapy+ standard care

    Standard care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Clinical improvement based on the 7-point scale
    A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
    Lower Murray lung injury score
    Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
    Lower Murray lung injury score
    Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.

    Secondary Outcome Measures

    28-day mortality
    Number of deaths during study follow-up
    Duration of mechanical ventilation
    Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
    Duration of hospitalization
    Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
    Proportion of patients with negative RT-PCR results
    Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
    Proportion of patients in each category of the 7-point scale
    Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
    Proportion of patients with normalized inflammation factors
    Proportion of patients with different inflammation factors in normalization range.
    Frequency of Adverse Drug Events
    Frequency of Adverse Drug Events
    Frequency of Serious Adverse Drug Events
    Frequency of Serious Adverse Drug Events

    Full Information

    First Posted
    February 6, 2020
    Last Updated
    February 6, 2020
    Sponsor
    Peking Union Medical College Hospital
    Collaborators
    Tongji Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04261426
    Brief Title
    The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
    Official Title
    A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 10, 2020 (Anticipated)
    Primary Completion Date
    April 30, 2020 (Anticipated)
    Study Completion Date
    June 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital
    Collaborators
    Tongji Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.
    Detailed Description
    In December 2019, viral pneumonia caused by a novel beta-coronavirus (2019-nCoV) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-nCoV pneumonia besides the supportive care. Intravenous immunoglobulin (IVIG) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. We hypothesized that IVIG therapy would improve the prognosis of severe and critically ill patients with 2019-nCoV. This single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of IVIG therapy in patients with severe or critically ill 2019-nCoV respiratory disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    2019-nCoV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IVIG therapy+ standard care
    Arm Type
    Experimental
    Arm Title
    Standard care
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Immunoglobulin
    Other Intervention Name(s)
    Human Immunoglobulin (pH4) for Intravenous Injection
    Intervention Description
    IVIG 0.5g/kg/d for 5 days
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Intervention Description
    Standard care
    Primary Outcome Measure Information:
    Title
    Clinical improvement based on the 7-point scale
    Description
    A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
    Time Frame
    28 days after randomization
    Title
    Lower Murray lung injury score
    Description
    Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
    Time Frame
    7 days after randomization
    Title
    Lower Murray lung injury score
    Description
    Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
    Time Frame
    14 days after randomization
    Secondary Outcome Measure Information:
    Title
    28-day mortality
    Description
    Number of deaths during study follow-up
    Time Frame
    Measured from Day 0 through Day 28
    Title
    Duration of mechanical ventilation
    Description
    Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
    Time Frame
    Measured from Day 0 through Day 28
    Title
    Duration of hospitalization
    Description
    Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
    Time Frame
    Measured from Day 0 through Day 28
    Title
    Proportion of patients with negative RT-PCR results
    Description
    Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
    Time Frame
    7 and 14 days after randomization
    Title
    Proportion of patients in each category of the 7-point scale
    Description
    Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
    Time Frame
    7,14 and 28 days after randomization
    Title
    Proportion of patients with normalized inflammation factors
    Description
    Proportion of patients with different inflammation factors in normalization range.
    Time Frame
    7 and 14 days after randomization
    Title
    Frequency of Adverse Drug Events
    Description
    Frequency of Adverse Drug Events
    Time Frame
    Measured from Day 0 through Day 28
    Title
    Frequency of Serious Adverse Drug Events
    Description
    Frequency of Serious Adverse Drug Events
    Time Frame
    Measured from Day 0 through Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult aged >=18years old; Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples; The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used; Meet any of the following criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=90%; or PaO2/FiO2<=300mmHg; or Respiratory failure and needs mechanical ventilation; or Shock occurs; or Multiple organ failure and needs ICU monitoring; Sign the Informed Consent Form on a voluntary basis. Exclusion Criteria: Exist of other evidences that can explain pneumonia including but not limited to: influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.; Allergy to Intravenous Immunoglobulin or its preparation components; Patients with selective IgA deficiency Women who are pregnant or breast-feeding; Researchers consider unsuitable.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Taisheng Li
    Phone
    010-69155086
    Email
    litsh@263.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Cao
    Email
    wcao_pumch@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia

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