Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Renmin Hospital of Wuhan University
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 COVID-19: confirmed cases shall be in compliance with guideline of "Diagnosis and Treatment Plan for COVID-19 (Version 7)" or updated versions.Confirmed cases can be defined if suspected cases have characteristic of following pathogeny or serology: 1) Detect nucleic acid of novel coronavirus positive by real-time fluorescence RT-PCR; 2) Have highly homologous to known novel coronavirus by sequencing; 3) Detect sero specific lgM and lgG positive; IgG specific against new coronavirus positive conversion or the titer of IgG is 4 times higher in convalescent period than in acute period; Adult patients with severe COVID-19 shall meet any of the following: 1) Respiratory distress, RR>=30 times / minute; 2) In the resting state, the oxygen saturation is <=93%; 3) For lung radiology, the lesion has obtained more than 50% obvious improvement within 24-48 hours; 4) 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: 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 1 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 |
|---|---|
| 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 |
|---|---|
| Improving time of main clinical symptoms(wheezing, cough, sputum, etc);ICU hospitalization days;14 and 28-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactBinghong Zhang
Renmin Hospital of Wuhan University
Outcome results
None listed