Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Novel coronavirus broad-spectrum neutralizing antibody SA55 injection (SA55 injection) is developed and produced by Beijing Kexing Zhongwei Biologics Technology Co., Ltd. The main component of SA55 injection is novel coronavirus broad-spectrum neutralizing antibody SA55. Each milliliter contains 150 mg of novel coronavirus broad-spectrum neutralizing antibody SA55. Excipients include histidine hydrochloride, arginine hydrochloride, histidine hydrochloride, sucrose, and polysorbate 80 (II)
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGEvaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients
Changes of novel coronavirus (SARS-CoV-2) load from baseline to D3, D5, D7
Time frame: from baseline to D3, D5, D7
Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients
The incidence of adverse events; The incidence of serious adverse events
Time frame: an average of 1 year
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on virological indicators)
(1) Changes in SARS-CoV-2 virus load relative to baseline at different time points; (2) Time to achieve continuous negative conversion of SARS-CoV-2 nucleic acid; (3) The proportion of subjects who achieved continuous negative SARS-CoV-2 nucleic acid conversion at different time points
Time frame: (1) D9, D11, D15 (2) After administration (3) D3, D5, D7, D9, D11, D15
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on clinical indicators)
Within 28 days after administration: the time of continuous disappearance of clinical symptoms and the time of continuous remission of clinical symptoms of 5, 7 and 11 COVID-19; The proportion of subjects who progress to severe/critically ill conditions; Hospitalization rate due to COVID-19; All cause mortality rate; Rescue treatment rate; Change of clinical symptom score of COVID-19 from baseline to different time points
Time frame: an average of 1 year
Evaluate the pharmacokinetic characteristics of SA55 injection in mild or moderate COVID-19 patients
Serum pharmacokinetic parameters of SA55 after medication (peak time Tmax, peak concentration Cmax, area under the drug time curve AUC0-t, AUC0- ∞, elimination half-life t1/2, apparent clearance rate CL/F, apparent distribution volume Vd/F, etc.)
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Time frame: an average of 1 year
Evaluation of serum COVID-19 neutralizing activity at different time points
Serum pharmacokinetic parameters of SA55 after medication (peak time Tmax, peak concentration Cmax, area under the drug time curve AUC0-t, AUC0- ∞, elimination half-life t1/2, apparent clearance rate CL/F, apparent distribution volume Vd/F, etc.)
Time frame: an average of 1 year
Evaluating the immunogenicity of SA55 injection
Serum anti drug antibody (ADA) levels at different time points
Time frame: an average of 1 year