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Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients

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ClinicalTrials.gov Identifier: NCT04264858
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Xiang Cheng, Wuhan Union Hospital, China

Brief Summary:
The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.

Condition or disease Intervention/treatment Phase
2019-nCoV Immunoglobulin of Cured Patients Drug: Immunoglobulin of cured patients Drug: γ-Globulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
Estimated Study Start Date : March 17, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Treatment group
Immunoglobulin of cured patients
Drug: Immunoglobulin of cured patients
0.2g/kg, ivdrip, once a day, for 3 days

Placebo Comparator: Control group
γ-Globulin
Drug: γ-Globulin
0.2g/kg, ivdrip, once a day, for 3 days




Primary Outcome Measures :
  1. Time to Clinical Improvement (TTCI) [ Time Frame: up to 28 days ]

    TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).

    Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge.

    Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.



Secondary Outcome Measures :
  1. Clinical status assessed by the ordinal scale [ Time Frame: up to 28 days ]
    on days 7, 14, 21, and 28

  2. The differences in oxygen intake methods [ Time Frame: up to 28 days ]
    1. No need for supplemental oxygenation; 2. nasal cathete oxygen inhalation;3. Mask oxygen inhalation;4. Noninvasive ventilator oxygen supply;5. Invasive ventilator oxygen supply.

  3. Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
  4. Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
  5. The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
  6. The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]
    The detection frequency could be increased according to clinician's decision

  7. Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
  8. Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]
    The antibody titer is detected on days 3 and 28

  9. Length of hospital stay (days) [ Time Frame: up to 28 days ]
  10. All cause mortality [ Time Frame: up to 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Volunteers who have understood and signed the informed consent;
  2. Age ≥18 years, gender unlimited;
  3. Patients diagnosed with acute severe 2019-nCoV pneumonia:

    1. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
    2. Lung involvement confirmed with pulmonary CT scan.
    3. At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.

Exclusion Criteria:

  1. Viral pneumonia with other viruses besides 2019-nCoV.
  2. Patients are not suitable for immunoglobulin therapy.
  3. Participation in other studies.
  4. Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.

Information from the National Library of Medicine

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): NCT04264858


Locations
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China, Hubei
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Wuhan Union Hospital, China
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Responsible Party: Xiang Cheng, Head of department of cardiology, Wuhan Union Hospital, China, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04264858    
Other Study ID Numbers: WuhanUH-2019 nCoV-Ig
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Immunologic Factors
Physiological Effects of Drugs