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

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ClinicalTrials.gov Identifier: NCT04261426
Recruitment Status : Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE February 6, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date February 7, 2020
Estimated Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Clinical improvement based on the 7-point scale [ Time Frame: 28 days after randomization ]
    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 [ Time Frame: 7 days after randomization ]
    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 [ Time Frame: 14 days after randomization ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • 28-day mortality [ Time Frame: Measured from Day 0 through Day 28 ]
    Number of deaths during study follow-up
  • Duration of mechanical ventilation [ Time Frame: Measured from Day 0 through Day 28 ]
    Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
  • Duration of hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]
    Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
  • Proportion of patients with negative RT-PCR results [ Time Frame: 7 and 14 days after randomization ]
    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 [ Time Frame: 7,14 and 28 days after randomization ]
    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 [ Time Frame: 7 and 14 days after randomization ]
    Proportion of patients with different inflammation factors in normalization range.
  • Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]
    Frequency of Adverse Drug Events
  • Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]
    Frequency of Serious Adverse Drug Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
Official Title  ICMJE A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE 2019-nCoV
Intervention  ICMJE
  • Drug: Intravenous Immunoglobulin
    IVIG 0.5g/kg/d for 5 days
    Other Name: Human Immunoglobulin (pH4) for Intravenous Injection
  • Other: Standard care
    Standard care
Study Arms  ICMJE
  • Experimental: IVIG therapy+ standard care
    Interventions:
    • Drug: Intravenous Immunoglobulin
    • Other: Standard care
  • Placebo Comparator: Standard care
    Intervention: Other: Standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Taisheng Li 010-69155086 litsh@263.net
Contact: Wei Cao wcao_pumch@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04261426
Other Study ID Numbers  ICMJE IVIG-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party LI Taisheng, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP