A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
Overview
- Phase
- Phase 2
- Intervention
- Intravenous Immunoglobulin
- Conditions
- 2019-nCoV
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 80
- Primary Endpoint
- Lower Murray lung injury score
- Last Updated
- 6 years ago
Overview
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.
Investigators
LI Taisheng
Director of Infectious Disease, Principal Investigator
Peking Union Medical College Hospital
Eligibility 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:
- •Respiratory rate \>=30/min; or
- •Rest SPO2\<=90%; or
- •PaO2/FiO2\<=300mmHg; or
- •Respiratory failure and needs mechanical ventilation; or
- •Shock occurs; or
- •Multiple organ failure and needs ICU monitoring;
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.
Arms & Interventions
IVIG therapy+ standard care
Intervention: Intravenous Immunoglobulin
IVIG therapy+ standard care
Intervention: Standard care
Standard care
Intervention: Standard care
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- Duration of hospitalization(Measured from Day 0 through Day 28)
- 28-day mortality(Measured from Day 0 through Day 28)
- Proportion of patients with negative RT-PCR results(7 and 14 days after randomization)
- Frequency of Adverse Drug Events(Measured from Day 0 through Day 28)
- Frequency of Serious Adverse Drug Events(Measured from Day 0 through Day 28)
- Proportion of patients with normalized inflammation factors(7 and 14 days after randomization)
- Duration of mechanical ventilation(Measured from Day 0 through Day 28)
- Proportion of patients in each category of the 7-point scale(7,14 and 28 days after randomization)