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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3; Phase 2

Conditions: 2019-nCoV

Treatments: Drug: Intravenous Immunoglobulin; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04261426

IVIG-001

Details and patient eligibility

About

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.

Full description

In December 2019, viral pneumonia caused by a novel beta-coronavirus (2019-nCoV) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-nCoV pneumonia besides the supportive care.

Intravenous immunoglobulin (IVIG) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. We hypothesized that IVIG therapy would improve the prognosis of severe and critically ill patients with 2019-nCoV.

This single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of IVIG therapy in patients with severe or critically ill 2019-nCoV respiratory disease.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

IVIG therapy+ standard care

Experimental group

Treatment:

Other: Standard care

Drug: Intravenous Immunoglobulin

Standard care

Placebo Comparator group

Treatment:

Other: Standard care