Clinical trial NCT04261426: The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
Official title: A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: 2019-nCoV
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
First posted: 2020-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Clinical improvement based on the 7-point scale
timeFrame: 28 days after randomization
measure: Lower Murray lung injury score
timeFrame: 7 days after randomization
measure: Lower Murray lung injury score
timeFrame: 14 days after randomization
Secondary outcomes:
measure: 28-day mortality
timeFrame: Measured from Day 0 through Day 28
measure: Duration of mechanical ventilation
timeFrame: Measured from Day 0 through Day 28
measure: Duration of hospitalization
timeFrame: Measured from Day 0 through Day 28
measure: Proportion of patients with negative RT-PCR results
timeFrame: 7 and 14 days after randomization
measure: Proportion of patients in each category of the 7-point scale
timeFrame: 7,14 and 28 days after randomization
measure: Proportion of patients with normalized inflammation factors
timeFrame: 7 and 14 days after randomization
measure: Frequency of Adverse Drug Events
timeFrame: Measured from Day 0 through Day 28
measure: Frequency of Serious Adverse Drug Events
timeFrame: Measured from Day 0 through Day 28
Other outcomes:
Locations:
Study officials:
References: