Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old, inpatients, male or female; 2. Patients with severe novel coronavirus infection: According to the "Pneumonitis Diagnosis and Treatment Guideline for the Novel Coronavirus Infection (Trial Version 5)", clinically diagnosed cases (suspected cases with pneumonia imaging features) or suspected cases. Severe patients must also meet any of the following: 1) Respiratory distress, RR>=30 times / minute 2) In the resting state, the oxygen saturation is <=93%; 3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300 mmHg (1mm Hg = 0.133 kPa). 3. Subjects and / or legal guardians of the subjects volunteered to participate in the study and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The clinical classification of patients with severe novel coronavirus infection is to meet any of the following: 1) Respiratory failure occurs and requires mechanical ventilation; 2) Shock occurs; 3) Combined failure of other organs requires ICU monitoring and treatment; 2. Those who are allergic to blood products or plasma components and auxiliary materials (sodium citrate); 3. There is multiple organ failure, and the estimated survival time is less than 3 days; 4. Those who tested positive for HIV antibodies before enrollment; 5. Women who are pregnant or breastfeeding or have a birth plan within the past year; 6. Participants in other clinical trials within 3 months before screening; Poor adherence or other conditions that the investigator believes are not suitable for inclusion (such as poor physical condition).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of clinical symptoms (Clinical improvement is defined as a reduction of 2 points on the 6-point scale of the patient's admission status or discharge from the hospital); | — |
Secondary
| Measure | Time frame |
|---|---|
| Main clinical manifestations subsided or significantly improved (fever, dry cough, fatigue, etc.);ICU hospitalization days;14 and 28-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactZhang Dingyu
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Outcome results
None listed