NCT04261426

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

A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 2019-nCoV

Interventions

Type	Name	Description
DRUG	Intravenous Immunoglobulin	IVIG 0.5g/kg/d for 5 days
OTHER	Standard care	Standard care

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-04-30
• Completion: 2020-06-30
• First posted: 2020-02-07
• Last updated: 2020-02-07