The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
NCT ID: NCT04261426
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2020-02-10
2020-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IVIG therapy+ standard care
Intravenous Immunoglobulin
IVIG 0.5g/kg/d for 5 days
Standard care
Standard care
Standard care
Standard care
Standard care
Interventions
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Intravenous Immunoglobulin
IVIG 0.5g/kg/d for 5 days
Standard care
Standard care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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LI Taisheng
Director of Infectious Disease, Principal Investigator
Central Contacts
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Other Identifiers
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IVIG-001
Identifier Type: -
Identifier Source: org_study_id
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