Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
eperimental group:Conventional treatment and convalescent plasma therapy
control group:conventional treatment
Sponsors
China-Japan friendship hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient signed an informed consent form to participate in the study of convalescent plasma therapy; 2. patient aged >=18 years old; 3. COVID-19 patients diagnosed by PCR; 4. Nucleic acid positive within 72 hours before blood transfusion; 5. Pneumonia confirmed by imaging; 6. Hospitalization for the following reason: Fever: axillary temperature>=36.7 degree C, or oral temperature>=38.0 degree C, or anal or ear temperature=38.6 ? And respiratory rate> 24 beats / min or cough (at least one of the two); 7. There are severe clinical warning indicators: such as a progressive decrease in peripheral blood lymphocytes, a progressive increase in peripheral blood inflammatory factors, a progressive increase in lactic acid, and rapid progress of lung lesions in the short term, et al. 8. Accept random grouping into any group; 9. The patient was hospitalized before the end of the clinical study. 10. Willing to participate in all necessary research directions and be able to participate in follow-up; 11. During the period of participating in this study, they will no longer participate in clinical trials such as other antiviral drugs.
Exclusion criteria
Exclusion criteria: 1. The doctor believes that the patient is not suitable to participate in this trial, including those who may not cooperate, do not comply with the requirements of the procedure, or participate in this trial may put the patient in an unsafe situation. 2. Pregnant or lactation periods women; 3. Immunoglobulin allergy; 4. Immunoglobulin A deficiency; 5. The clinical symptoms are mild or reach the standard of severe or critical. Mild symptoms: Clinical symptoms are mild and no pneumonia on imaging. Severe patients meet any of the following: 1) respiratory distress, RR >=30 beats / min; 2) in resting state, oxygen saturation <=93%; 3) partial pressure of oxygen in arterial blood (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg=0.133kPa) Critically ill patients meet any of the following: 1) respiratory failure and need mechanical ventilation; 2) shock; 3) patients with other organ failure need ICU monitoring treatment. 6. There are diseases that may increase the risk of thrombosis, such as cold globulinemia, severe refractory hypertriglyceridemia, clinically defined monoclonal gamma globulinemia, etc. 7. High titer of anti-novel coronavirus antibody RBDIgG (higher than 1) could be detected. 8. Received any experimental treatment for novel coronavirus infection within 30 days before screening; 9. The researchers judged that the patients had the following life-threatening conditions, including, but not limited to, Phammer F < 100mmHg, near-death state or expected survival time less than 24 hours, severe septic shock or disseminated intravascular coagulation ((DIC)), etc., 10. Severe congestive heart failure, or other relative contraindications for plasma transfusion determined by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical recovery after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality;Hospitalization time;Incidence of breathing exacerbations;Time for conscious cough relief during infection (cough present when enrolled);Time to remission of conscious dyspnea during infection (existed dyspnea upon enrollment);28-day assisted oxygen therapy or non-invasive mechanical ventilation rate;Incidence of ICU surveillance required during infection;Incidence of clinical support measures increased during infection;Proportion of viral nucleic acid negative;Cumulative incidence of severe adverse events (SAE);Cumulative incidence of adverse events (AE), grades 3 and 4 AE;Incidence of adverse plasma transfusion reactions; | — |
Countries
China
Contacts
Public ContactCao Bin
China-Japan Friendship Hospital
Outcome results
None listed