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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
IVIG 0.5g/kg/d for 5 days
Standard care
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).
Time frame: 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.
Time frame: 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.
Time frame: 14 days after randomization
28-day mortality
Number of deaths during study follow-up
Time frame: 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.
Time frame: Measured from Day 0 through Day 28
Duration of hospitalization
Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Time frame: 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.
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Time frame: 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).
Time frame: 7,14 and 28 days after randomization
Proportion of patients with normalized inflammation factors
Proportion of patients with different inflammation factors in normalization range.
Time frame: 7 and 14 days after randomization
Frequency of Adverse Drug Events
Frequency of Adverse Drug Events
Time frame: Measured from Day 0 through Day 28
Frequency of Serious Adverse Drug Events
Frequency of Serious Adverse Drug Events
Time frame: Measured from Day 0 through Day 28