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

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

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.

Study Overview

• Status: Unknown
• Conditions: 2019-nCoV; Immunoglobulin of Cured Patients
• Intervention / Treatment: Drug: Immunoglobulin of cured patients; Drug: γ-Globulin

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
All cause mortality		up to 28 days
Length of hospital stay (days)		up to 28 days
The mean PaO2/FiO2		up to 28 days
Duration (days) of mechanical ventilation		up to 28 days
Duration (days) of supplemental oxygenation		up to 28 days
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
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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Anticipated): March 17, 2020
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: February 8, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins
• Other Study ID Numbers: WuhanUH-2019 nCoV-Ig

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No