Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Conventional treatment and anti-SARS-CoV-2 virus inactivated plasma
Control group:Conventional treatment and Ordinary plasma
Sponsors
First people's hospital of Jiangxi district,Wuhan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Patients with pneumonia infected by new coronavirus: confirmed cases in compliance with the Diagnosis and Treatment Plan for Pneumonia Infected by New Coronavirus (Sixth Edition); 3. Confirmed cases who can be transfused into anti-SARS-CoV-2 virus inactivated plasma after fully assessing patients condition; 4. Cases who score 3 or 4 according to 6-grade scale; 5. The subjects and/or their legal guardians voluntarily participated in the study and voluntarily signed an informed consent form.
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; 7.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 |
|---|---|
| Clinical symptom improvement rate: improvement rate of clinical symptoms = number of cases with clinical symptom improvement /number of enrolling cases * 100%; | — |
Secondary
| Measure | Time frame |
|---|---|
| The fading and obviously improving time of clinical symptoms (fever, dry cough, fatigue, etc);The negative conversion rate of SARS-CoV-2 nucleic acid;Negative conversion time of SARS-CoV-2 nucleic acid;Abatement rate of fever transfusion .The definition of abatement rate refers to the case percentage with <37.5? axillary temperature and the maintenance of at least 48h.;Antibody levels of SARS-CoV-2;The absorbance of lung lesion (based on CT) ;Time of discharge; | — |
Countries
China
Contacts
Public ContactBende Liu
First people's hospital of Jiangxi district, Wuhan
Outcome results
None listed