The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia

• Status: Not yet recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Tongji Hospital; Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Adult aged >=18years old;

• Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;

• The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;

• Meet any of the following criteria for severe or critical ill conditions:

1. Respiratory rate >=30/min; or

2. Rest SPO2<=90%; or

3. PaO2/FiO2<=300mmHg; or

4. Respiratory failure and needs mechanical ventilation; or

5. Shock occurs; or

6. Multiple organ failure and needs ICU monitoring;

• Sign the Informed Consent Form on a voluntary basis.

Exclusion Criteria:

• Exist of other evidences that can explain pneumonia including but not limited to:

influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;

• Allergy to Intravenous Immunoglobulin or its preparation components;

• Patients with selective IgA deficiency

• Women who are pregnant or breast-feeding;

• Researchers consider unsuitable.