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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
2019-nCoV Drug: Intravenous Immunoglobulin Other: Standard care Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 10, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: IVIG therapy+ standard care Drug: Intravenous Immunoglobulin
IVIG 0.5g/kg/d for 5 days
Other Name: Human Immunoglobulin (pH4) for Intravenous Injection

Other: Standard care
Standard care

Placebo Comparator: Standard care Other: Standard care
Standard care




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: Measured from Day 0 through Day 28 ]
    Number of deaths during study follow-up

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]
    Frequency of Adverse Drug Events

  8. Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]
    Frequency of Serious Adverse Drug Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261426


Contacts
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Contact: Taisheng Li 010-69155086 litsh@263.net
Contact: Wei Cao wcao_pumch@163.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Responsible Party: LI Taisheng, Director of Infectious Disease, Principal Investigator, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04261426    
Other Study ID Numbers: IVIG-001
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs