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

• ClinicalTrials.gov Identifier: NCT04261426
• Recruitment Status: Unknown
• First Posted: February 7, 2020
• Last Update Posted: February 7, 2020
• Sponsor: Peking Union Medical College Hospital
• Collaborator: Tongji Hospital
• Information provided by (Responsible Party): LI Taisheng, Peking Union Medical College Hospital

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

More Information

• 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
• Last Update Posted: February 7, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin; Immunologic Factors; Physiological Effects of Drugs