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
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology |
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 |
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