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

A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia

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.

Study Overview

• Status: Unknown
• Conditions: 2019-nCoV
• Intervention / Treatment: Other: Standard care; Drug: Intravenous Immunoglobulin

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: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Taisheng Li; Phone Number: 010-69155086; Email: litsh@263.net
• Study Contact Backup: Name: Wei Cao; Email: wcao_pumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVIG therapy+ standard care	Other: Standard care; Standard care; Drug: Intravenous Immunoglobulin; IVIG 0.5g/kg/d for 5 days; Other Names: Human Immunoglobulin (pH4) for Intravenous Injection
Placebo Comparator: Standard care	Other: Standard care; Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	28 days after randomization
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.	7 days after randomization
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.	14 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Number of deaths during study follow-up	Measured from Day 0 through Day 28
Duration of mechanical ventilation	Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.	Measured from Day 0 through Day 28
Duration of hospitalization	Days that a participant spent at the hospital. Multiple hospitalizations are summed up.	Measured from Day 0 through Day 28
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.	7 and 14 days after randomization
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).	7,14 and 28 days after randomization
Proportion of patients with normalized inflammation factors	Proportion of patients with different inflammation factors in normalization range.	7 and 14 days after randomization
Frequency of Adverse Drug Events	Frequency of Adverse Drug Events	Measured from Day 0 through Day 28
Frequency of Serious Adverse Drug Events	Frequency of Serious Adverse Drug Events	Measured from Day 0 through Day 28

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 10, 2020
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: IVIG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No