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

Huazhong University of Science and Technology

Status: Unknown

Conditions: 2019-nCoV; Immunoglobulin of Cured Patients

Treatments: Drug: γ-Globulin; Drug: Immunoglobulin of cured patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04264858

WuhanUH-2019 nCoV-Ig

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

Immunoglobulin of cured patients

Treatment:

Drug: Immunoglobulin of cured patients

Control group

Placebo Comparator group

Description:

γ-Globulin

Treatment:

Drug: γ-Globulin