Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers who have understood and signed the informed consent; 2. Aged >=18 years; 3. Patients diagnosed with acute severe 2019-nCoV pneumonia: (1) Laboratory (RT-PCR) confirmed infection with 2019-nCoV. (2) Lung involvement confirmed with pulmonary CT scan; (3) At least one of the following conditions should be met: respiratory distress, RR >=30 times/min; oxygen saturation <=93% in resting state; PaO2/FiO2 <=300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.
Exclusion criteria
Exclusion criteria: 1. Viral pneumonia with other viruses besides 2019-nCoV; 2. Patients are not suitable for immunoglobulin therapy; 3. Participation in other studies; 4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical Improvement (TTCI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical status assessed by the ordinal scale;The differences in oxygen intake methods;Duration (days) of supplemental oxygenation;Duration (days) of mechanical ventilation;The mean PaO2/FiO2;The lesions of the pulmonary segment numbers involved in pulmonary CT;Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens;Dynamic changes of 2019-nCoV antibody titer in blood;Length of hospital stay (days);All cause mortality; | — |
Countries
China
Contacts
Union hospital of Tongji Medical College, Huazhong University of Science and Technology