Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients

Conditions
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2019-nCoV, Immunoglobulin of Cured Patients

Intervention / Treatment
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* Drug: Immunoglobulin of cured patients
* Drug: γ-Globulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers who have understood and signed the informed consent; Age ≥18 years, gender unlimited; Patients diagnosed with acute severe 2019-nCoV pneumonia: Laboratory (RT-PCR) confirmed infection with 2019-nCoV. Lung involvement confirmed with pulmonary CT scan. 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: Viral pneumonia with other viruses besides 2019-nCoV. Patients are not suitable for immunoglobulin therapy. Participation in other studies. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Immunoglobulin of cured patients | Drug: Immunoglobulin of cured patients<br>* 0.2g/kg, ivdrip, once a day, for 3 days<br>|
| Placebo Comparator: Control group<br>γ-Globulin | Drug: γ-Globulin<br>* 0.2g/kg, ivdrip, once a day, for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Clinical Improvement (TTCI) | 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. | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status assessed by the ordinal scale | on days 7, 14, 21, and 28 | up to 28 days | 
| The differences in oxygen intake methods | 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. | up to 28 days | 
| 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 | 
| The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] | The detection frequency could be increased according to clinician's decision | up to 28 days | 
| 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 | The antibody titer is detected on days 3 and 28 | up to 28 days | 
| Length of hospital stay (days) |  | up to 28 days | 
| All cause mortality |  | up to 28 days |