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

Phase 2

• Conditions: 2019-nCoV
• Interventions: Other: Standard care; Drug: Intravenous Immunoglobulin

• Registration Number: NCT04261426
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Study First Posted: 2020-02-07
• Last Update Posted: 2020-02-07
• Study Start: 2020-02-10
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	-
IVIG therapy+ standard care	Intravenous Immunoglobulin	-
IVIG therapy+ standard care	Standard care	-

Primary Outcome Measures

Name	Time	Method
Lower Murray lung injury score	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.
Clinical improvement based on the 7-point scale	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).

Secondary Outcome Measures

Name	Time	Method
28-day mortality	Measured from Day 0 through Day 28	Number of deaths during study follow-up
Duration of hospitalization	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	7 and 14 days after randomization	Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Frequency of Adverse Drug Events	Measured from Day 0 through Day 28	Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events	Measured from Day 0 through Day 28	Frequency of Serious Adverse Drug Events
Proportion of patients with normalized inflammation factors	7 and 14 days after randomization	Proportion of patients with different inflammation factors in normalization range.
Duration of mechanical ventilation	Measured from Day 0 through Day 28	Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Proportion of patients in each category of the 7-point scale	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).