The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
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|ClinicalTrials.gov Identifier: NCT04261426|
Recruitment Status : Unknown
Verified February 2020 by LI Taisheng, Peking Union Medical College Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
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|Condition or disease||Intervention/treatment||Phase|
|2019-nCoV||Drug: Intravenous Immunoglobulin Other: Standard care||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
|Experimental: IVIG therapy+ standard care||
Drug: Intravenous Immunoglobulin
IVIG 0.5g/kg/d for 5 days
Other Name: Human Immunoglobulin (pH4) for Intravenous Injection
Other: Standard care
|Placebo Comparator: Standard care||
Other: Standard care
- Clinical improvement based on the 7-point scale [ Time Frame: 28 days after randomization ]A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
- Lower Murray lung injury score [ Time Frame: 7 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
- Lower Murray lung injury score [ Time Frame: 14 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
- 28-day mortality [ Time Frame: Measured from Day 0 through Day 28 ]Number of deaths during study follow-up
- Duration of mechanical ventilation [ Time Frame: Measured from Day 0 through Day 28 ]Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
- Duration of hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
- Proportion of patients with negative RT-PCR results [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
- Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
- Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
- Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
- Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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:
- Respiratory rate >=30/min; or
- Rest SPO2<=90%; or
- PaO2/FiO2<=300mmHg; or
- Respiratory failure and needs mechanical ventilation; or
- Shock occurs; or
- Multiple organ failure and needs ICU monitoring;
- Sign the Informed Consent Form on a voluntary basis.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261426
|Contact: Taisheng Lifirstname.lastname@example.org|
|Contact: Wei Caoemail@example.com|
|Responsible Party:||LI Taisheng, Director of Infectious Disease, Principal Investigator, Peking Union Medical College Hospital|
|Other Study ID Numbers:||
|First Posted:||February 7, 2020 Key Record Dates|
|Last Update Posted:||February 7, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
Respiratory Tract Diseases
Rho(D) Immune Globulin
Physiological Effects of Drugs