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

2019-nCoV Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04261426
• Other study ID #: IVIG-001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: February 10, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2020
• Source: Peking Union Medical College Hospital
• Contact: Taisheng Li
• Phone: 010-69155086
• Email: litsh[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 2019-nCoV
• Pneumonia

Intervention

Drug:
• Intravenous Immunoglobulin
IVIG 0.5g/kg/d for 5 days

Other:
• Standard care
Standard care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	28-day mortality	Number of deaths during study follow-up	Measured from Day 0 through Day 28
Secondary	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
Secondary	Duration of hospitalization	Days that a participant spent at the hospital. Multiple hospitalizations are summed up.	Measured from Day 0 through Day 28
Secondary	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
Secondary	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
Secondary	Proportion of patients with normalized inflammation factors	Proportion of patients with different inflammation factors in normalization range.	7 and 14 days after randomization
Secondary	Frequency of Adverse Drug Events	Frequency of Adverse Drug Events	Measured from Day 0 through Day 28
Secondary	Frequency of Serious Adverse Drug Events	Frequency of Serious Adverse Drug Events	Measured from Day 0 through Day 28