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

Primary Purpose

2019-nCoV, Immunoglobulin of Cured Patients

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Immunoglobulin of cured patients
γ-Globulin
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 2019-nCoV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

Immunoglobulin of cured patients

γ-Globulin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical status assessed by the ordinal scale
on days 7, 14, 21, and 28
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.
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 [ every 7 days]
The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]
Dynamic changes of 2019-nCoV antibody titer in blood
The antibody titer is detected on days 3 and 28
Length of hospital stay (days)
All cause mortality

Full Information

First Posted
February 8, 2020
Last Updated
March 13, 2020
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04264858
Brief Title
Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients
Official Title
An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2020 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019-nCoV, Immunoglobulin of Cured Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Immunoglobulin of cured patients
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
γ-Globulin
Intervention Type
Drug
Intervention Name(s)
Immunoglobulin of cured patients
Intervention Description
0.2g/kg, ivdrip, once a day, for 3 days
Intervention Type
Drug
Intervention Name(s)
γ-Globulin
Intervention Description
0.2g/kg, ivdrip, once a day, for 3 days
Primary Outcome Measure Information:
Title
Time to Clinical Improvement (TTCI)
Description
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.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Clinical status assessed by the ordinal scale
Description
on days 7, 14, 21, and 28
Time Frame
up to 28 days
Title
The differences in oxygen intake methods
Description
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.
Time Frame
up to 28 days
Title
Duration (days) of supplemental oxygenation
Time Frame
up to 28 days
Title
Duration (days) of mechanical ventilation
Time Frame
up to 28 days
Title
The mean PaO2/FiO2
Time Frame
up to 28 days
Title
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days]
Description
The detection frequency could be increased according to clinician's decision
Time Frame
up to 28 days
Title
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]
Time Frame
up to 28 days
Title
Dynamic changes of 2019-nCoV antibody titer in blood
Description
The antibody titer is detected on days 3 and 28
Time Frame
up to 28 days
Title
Length of hospital stay (days)
Time Frame
up to 28 days
Title
All cause mortality
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

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

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