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Exploratory study for Immunoglobulin From Cured COVID-19 Patients in the Treatment of Acute Severe novel coronavirus pneuvirus (COVID-19)

Treatment of Acute Severe COVID-19 With Immunoglobulin From Cured COVID-19 Patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030841
Enrollment
Unknown
Registered
2020-03-15
Start date
2020-02-17
Completion date
Unknown
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Experimental group:Immunoglobulin of cured patients
Control group:gama-Globulin

Sponsors

Union hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Volunteers who have understood and signed the informed consent; 2. Aged >=18 years; 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

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.

Design outcomes

Primary

MeasureTime frame
Time to Clinical Improvement (TTCI);

Secondary

MeasureTime frame
Clinical status assessed by the ordinal scale;The differences in oxygen intake methods;Duration (days) of supplemental oxygenation;Duration (days) of mechanical ventilation;The mean PaO2/FiO2;The lesions of the pulmonary segment numbers involved in pulmonary CT;Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens;Dynamic changes of 2019-nCoV antibody titer in blood;Length of hospital stay (days);All cause mortality;

Countries

China

Contacts

Public ContactXiang Cheng

Union hospital of Tongji Medical College, Huazhong University of Science and Technology

nathancx@hust.edu.cn+86 15972061080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026