2019-nCoV, Immunoglobulin of Cured Patients
Conditions
Brief summary
The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.
Interventions
DRUGImmunoglobulin of cured patients
0.2g/kg, ivdrip, once a day, for 3 days
DRUGγ-Globulin
0.2g/kg, ivdrip, once a day, for 3 days
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Volunteers who have understood and signed the informed consent; 2. Age ≥18 years, gender unlimited; 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
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 | Description |
|---|---|---|
| Time to Clinical Improvement (TTCI) | up to 28 days | TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The differences in oxygen intake methods | up to 28 days | 1\. No need for supplemental oxygenation; 2. nasal cathete oxygen inhalation；3. Mask oxygen inhalation；4. Noninvasive ventilator oxygen supply；5. Invasive ventilator oxygen supply. |
| Duration (days) of supplemental oxygenation | up to 28 days | — |
| Duration (days) of mechanical ventilation | up to 28 days | — |
| The mean PaO2/FiO2 | up to 28 days | — |
| Clinical status assessed by the ordinal scale | up to 28 days | on days 7, 14, 21, and 28 |
| Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] | up to 28 days | — |
| Dynamic changes of 2019-nCoV antibody titer in blood | up to 28 days | The antibody titer is detected on days 3 and 28 |
| Length of hospital stay (days) | up to 28 days | — |
| All cause mortality | up to 28 days | — |
| The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] | up to 28 days | The detection frequency could be increased according to clinician's decision |
Countries
China
Outcome results
None listed