SA55 Injection Phase II Study in the Treatment of Mild/Mo... | NCT06042764

NCT06042764

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
SA55 Injection	Experimental	Group 1: 300 mg Group 2: 600 mg	Drug: SA55 Injection
Placebo	Placebo Comparator	Group 1: 0 mg Group 2: 0 mg	Drug: SA55 Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SA55 Injection	Drug	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation 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	from baseline to D3, D5, D7

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients	The incidence of adverse events; The incidence of serious adverse events	an average of 1 year
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on virological indicators)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged ≥ 18 years on the day of enrollment;
On the day of enrollment, novel coronavirus nucleic acid test was positive and/or novel coronavirus antigen test was positive;
On the day of enrollment, it meets the criteria for mild or medium COVID-19 cases, and the time from the first COVID-19 infection related symptoms is within 72 hours;
Within 24 hours before enrollment, one or more of the following symptoms or signs must be present: a. fever, b. cough, c. sore throat, d. nasal congestion/runny nose, e. headache, f. muscle pain, g. shortness of breath/difficulty breathing, h. nausea, i. fatigue, j. vomiting, k. diarrhea;
Subjects (male and female of childbearing age) and their sexual partners voluntarily take effective contraceptive measures within 6 months after signing the informed consent form and administering the experimental drug, and do not have plans to donate sperm or eggs;
At rest, when inhaling air, the oxygen saturation is greater than 93%;
Subjects voluntarily participate in the experiment and sign an informed consent form before the start of the study.

Exclusion Criteria:

Individuals who are known to be allergic to the investigational drug, any component in the preparation, or other similar drugs;
Individuals weighing less than 40 kg;
There are comorbidities that require surgery within one month, or comorbidities that are considered life-threatening within one month;
Before screening, he has received neutralizing antibody drugs from COVID-19, or received human immunoglobulin or convalescent plasma treatment from convalescent patients within 3 months, or received small molecule drugs from COVID-19 within 7 days;
Suspected or confirmed to have combined serious and active bacterial, fungal, viral or other infections (except for COVID-19 infection), such as acute systemic infection, the researcher believes that intervention measures may pose a risk;
Individuals who tested positive for influenza A/B virus antigens during screening;
Plan to become pregnant within 6 months, already pregnant, or breastfeeding;
Participated in clinical trials of other drugs or medical devices within 3 months prior to screening;
Having/having suffered from severe neurological disorders (epilepsy, convulsions, or seizures) or mental illness, or having a family history of mental illness;
Suffering from/having previously suffered from severe neurological diseases or other serious illnesses that the researcher has determined to be unsuitable for participation in the study (including but not limited to current systemic infections, uncontrolled autoimmune diseases, uncontrolled immunodeficiency diseases, history of myocardial infarction or heart disease, etc.);
Unable to cooperate with the follow-up of the study, or unable to guarantee the non use of concomitant drugs/vaccines/treatments prohibited by this protocol during the study period (see section 6.4.2);
The researcher believes that due to other reasons, it is not suitable to participate in this study.