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

2019-nCoV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04264858
• Other study ID #: WuhanUH-2019 nCoV-Ig
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2020
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 2019-nCoV
• Immunoglobulin of Cured Patients
• Pneumonia

Intervention

Drug:
• Immunoglobulin of cured patients
0.2g/kg, ivdrip, once a day, for 3 days
• ?-Globulin
0.2g/kg, ivdrip, once a day, for 3 days

Locations

Country	Name	City	State
China	Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical status assessed by the ordinal scale	on days 7, 14, 21, and 28	up to 28 days
Secondary	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
Secondary	Duration (days) of supplemental oxygenation		up to 28 days
Secondary	Duration (days) of mechanical ventilation		up to 28 days
Secondary	The mean PaO2/FiO2		up to 28 days
Secondary	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
Secondary	Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]		up to 28 days
Secondary	Dynamic changes of 2019-nCoV antibody titer in blood	The antibody titer is detected on days 3 and 28	up to 28 days
Secondary	Length of hospital stay (days)		up to 28 days
Secondary	All cause mortality		up to 28 days