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Immunoglobulin of cured patientsWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1424 γ-Globulin Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.07

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.07

There is one clinical trial.

Clinical Trials

1 An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients

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.

NCT04264858 2019-nCoV Immunoglobulin of Cured Patients Drug: Immunoglobulin of cured patients Drug: γ-Globulin

Primary Outcomes

Description: 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.

Measure: Time to Clinical Improvement (TTCI)

Time: up to 28 days

Secondary Outcomes

Description: on days 7, 14, 21, and 28

Measure: Clinical status assessed by the ordinal scale

Time: up to 28 days

Description: 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.

Measure: The differences in oxygen intake methods

Time: up to 28 days

Measure: Duration (days) of supplemental oxygenation

Time: up to 28 days

Measure: Duration (days) of mechanical ventilation

Time: up to 28 days

Measure: The mean PaO2/FiO2

Time: up to 28 days

Description: The detection frequency could be increased according to clinician's decision

Measure: The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days]

Time: up to 28 days

Measure: Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]

Time: up to 28 days

Description: The antibody titer is detected on days 3 and 28

Measure: Dynamic changes of 2019-nCoV antibody titer in blood

Time: up to 28 days

Measure: Length of hospital stay (days)

Time: up to 28 days

Measure: All cause mortality

Time: up to 28 days

Related HPO nodes (Using clinical trials)