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

Not Applicable

• Conditions: 2019-nCoV; Immunoglobulin of Cured Patients
• Interventions: Drug: Immunoglobulin of cured patients; Drug: γ-Globulin

• Registration Number: NCT04264858
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Study Start: 2020-03-17
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Immunoglobulin of cured patients	Immunoglobulin of cured patients
Control group	γ-Globulin	γ-Globulin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]	up to 28 days
Clinical status assessed by the ordinal scale	up to 28 days	on days 7, 14, 21, and 28
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
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
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

Trial Locations

Locations (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China