Clinical trial NCT04264858: Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients
Official title: An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 2019-nCoV
Immunoglobulin of Cured Patients
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to Clinical Improvement (TTCI)
timeFrame: up to 28 days
Secondary outcomes:
measure: Clinical status assessed by the ordinal scale
timeFrame: up to 28 days
measure: The differences in oxygen intake methods
timeFrame: up to 28 days
measure: Duration (days) of supplemental oxygenation
timeFrame: up to 28 days
measure: Duration (days) of mechanical ventilation
timeFrame: up to 28 days
measure: The mean PaO2/FiO2
timeFrame: up to 28 days
measure: The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days]
timeFrame: up to 28 days
measure: Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]
timeFrame: up to 28 days
measure: Dynamic changes of 2019-nCoV antibody titer in blood
timeFrame: up to 28 days
measure: Length of hospital stay (days)
timeFrame: up to 28 days
measure: All cause mortality
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: