Novel Coronavirus Pneumonia
Conditions
Interventions
Case series:Anti-2019-nCoV virus inactivated plasma
Sponsors
First People's Hospital of Jiangxia District, Wuhan (Union Jiangnan Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Inpatients aged 18 to 80 years old, male or female; 2. Confirmed patient diagnosed according to the guideline for Diagnosis and Treatment for COVID-19 (5th version), whose clinical classification is common or severe case; Clinically diagnosed cases (suspected cases with radiological characteristics of pneumonia) or suspected cases have one of the following pathogenic evidences: 1) positive sputum or blood SARS-CoV-2 real-time RT-PCR assay; 2) Virus gene sequence from respiratory tract samples or blood samples, is highly homologous with SARS-CoV-2; 3. All subjects with childbearing ages must take effective contraceptive measures within 3 months after enrolling the screening period and after this clinical trial; 4. Full evaluation of the patient's condition, and confirmation that the patient can be transfused into convalescent plasma by doctors; 5. Volunteer to transfuse convalescent plasma, and sign the informed transfusion form and sign the notice of infusion (when neither the subject nor the legal guardian can read and understand the agreed contents of the notice of infusion, they need to sign it together with a third-party witness or/and his legal guardian or his legal representative to sign it together).
Exclusion criteria
Exclusion criteria: 1. Previous or current allergic history to human plasma protein products or excipients (sodium citrate) contained in this product; 2. Patients diagnosed as severe COVID-19; 3. Patients diagnosed as infection of influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, SARS virus and other known viral pneumonia; Patients diagnosed as mycoplasma pneumonia, chlamydia pneumonia and bacterial pneumonia; 4. Subjects who had suffered or suffered from deep vein thrombosis, pulmonary embolism or arterial embolism within 1 year before signing the informed transfusion form or currently; 5. Patients with severe heart disease, including myocardial infarction and chronic cardiac insufficiency (NYHA grades III and IV); 6. Researchers judge that patients with severe liver and kidney diseases who are not suitable for clinical trial; 7. Patients with positive HBsAg antigen (or nucleic acid test) or HCV antibody (or nucleic acid test) or HIV antibody (or nucleic acid test) or Treponema pallidum antibody; 8. Pregnant women or breast-feeding women or women of childbearing age or male subjects in childbearing age are unwilling to take contraceptive measures during the study period; 9. Participated in clinical trials for other drugs or medical devices within 1 month before signing the informed transfusion form; 10. Suffering from mental illness, obvious mental disorder or epilepsy; Patients with acute diseases; Patients with current or previous malignant tumor diseases; Incapable of behavior or cognition; 11. Alcoholics, drug addicts, drug abusers and addicts; 12. Poor compliance or any circumstances that other researchers believe are not suitable for inclusion (e.g. Expected survival time is less than 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of clinical symptom, laboratory and radiological data ;Oxyhemoglobin saturation.;dyspnea;Body temperature;Radiological characteristic sign;Blood routine;C-reaction protein;lymphocyte count;Liver function: TBIL(total bilirubin), AST(alanine aminotransferase) and ALT(aspartate aminotransferase);Neutralization antibody level; | — |
Secondary
| Measure | Time frame |
|---|---|
| The copy number of 2019-nCoV RNA; | — |
Countries
China
Contacts
Public ContactBende Liu
First People's Hospital of Jiangxia District, Wuhan (Union Jiangnan Hospital)
Outcome results
None listed