2019-nCoV Clinical Trial
Official title:
An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
Verified date | March 2020 |
Source | Wuhan Union Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | May 31, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wuhan Union Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Clinical Improvement (TTCI) | 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. |
up to 28 days | |
Secondary | Clinical status assessed by the ordinal scale | on days 7, 14, 21, and 28 | up to 28 days | |
Secondary | The differences in oxygen intake methods | 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. | up to 28 days | |
Secondary | Duration (days) of supplemental oxygenation | up to 28 days | ||
Secondary | Duration (days) of mechanical ventilation | up to 28 days | ||
Secondary | The mean PaO2/FiO2 | up to 28 days | ||
Secondary | The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] | The detection frequency could be increased according to clinician's decision | up to 28 days | |
Secondary | Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] | up to 28 days | ||
Secondary | Dynamic changes of 2019-nCoV antibody titer in blood | The antibody titer is detected on days 3 and 28 | up to 28 days | |
Secondary | Length of hospital stay (days) | up to 28 days | ||
Secondary | All cause mortality | up to 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT04334967 -
Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care
|
Phase 4 | |
Withdrawn |
NCT04272710 -
Prognositc Factors in COVID-19 Patients Complicated With Hypertension
|
||
Completed |
NCT04260594 -
Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus
|
Phase 4 | |
Active, not recruiting |
NCT04273763 -
Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)
|
N/A | |
Not yet recruiting |
NCT04270383 -
Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
|
||
Terminated |
NCT04261907 -
Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection
|
N/A | |
Not yet recruiting |
NCT04261426 -
The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
|
Phase 2/Phase 3 | |
Recruiting |
NCT04255017 -
A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
|
Phase 4 | |
Recruiting |
NCT04254874 -
A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia
|
Phase 4 | |
Not yet recruiting |
NCT04356508 -
COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
|
Phase 2 | |
Terminated |
NCT04321928 -
Personalized Health Education Against the Health Damage of Novel Coronavirus (COVID-19) Outbreak in Hungary
|
N/A |