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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG therapy+ standard care | Experimental |
| |
| Standard care | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Immunoglobulin | Drug | IVIG 0.5g/kg/d for 5 days |
|
| 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 |
| 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. |
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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:
Sign the Informed Consent Form on a voluntary basis.
Exclusion Criteria:
influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taisheng Li | Contact | 010-69155086 | litsh@263.net | |
| Wei Cao | Contact | wcao_pumch@163.com |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Standard care | Other | Standard care |
|
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |