COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50537

Cao Bin

caobin_ben@163.com

2020-03-10

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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.

2

China-Japan friendship hospital

18

None

China

Moderate disease at enrollment

3: Moderate disease at enrollment

50

Time to clinical recovery after randomization;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]