Official Title
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Novel Coronavirus Broad-spectrum Neutralizing Antibody SA55 Injection in the Treatment of Mild/Moderate COVID-19 Patients
Brief Summary

Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients

Detailed Description

Not Provided

Recruiting
Infection of Upper Respiratory Tract Caused by 2019-nCoV

Drug: SA55 Injection

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)

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Ruijin Hospital
Shanghai, Shanghai, China

Investigator: Guang Ning
Contact: 13501656999
guangning@medmail.com.cn

Contacts

Guang Ning, M.D.
13501656999
guangning@medmail.com.cn

Guang Ning, Principal Investigator
Ruijin Hospital

Sinovac Life Sciences Co., Ltd.
NCT Number
Keywords
2019-nCOV