COVID-19
Conditions
Interventions
Preventative group:A8G6 SARS-CoV-2 neutralization antibody combination nasal spray
Treatment group:A8G6 SARS-CoV-2 neutralization antibody combination nasal spray
Sponsors
Bishan Hospital of Chongqing Medical university, People's Hospital of Chongqing Banan District
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in the preventative group: 1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and sign informed consent; 2. The subjects and their partners are willing to have no family planning, voluntarily take effective contraceptive measures and have no sperm or egg donation plans from 2 weeks before screening to 3 months after the last administration of the study drug, and promise to use one or more non-drug contraceptive measures during sexual life from 2 weeks before screening to 1 month after the last administration of the study drug; 3. Healthy subjects aged from 12 to 65 years (including the boundary value, subject to the informed consent signed); 4. During the trial period (D-1~D7), except for this study, only samples of SARS-CoV-2 nucleic acid from oral and pharyngeal swabs will be taken, and no samples from nasopharyngeal swabs will be taken; 5. During the screening period, oral and pharyngeal swabs were taken and SARS-CoV-2 RNA Ct test results were negative (Ct value >= 35). Nasal/oropharyngeal swab results before signing informed consent were acceptable, but the interval between SARS-CoV-2 RNA Ct sampling time and first administration should be ensured to be no more than 24 hours. The minimum duration should not exceed 48 hours. Subjects must meet all of the following inclusion criteria to be enrolled in the treatment group: 1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and sign informed consent; 2. Subjects and their partners are willing to have no fertility plan and voluntarily take effective contraceptive measures from 2 weeks before screening to 3 months after the last dose of the study drug without sperm donation or egg donation plan, and ensure that one or more non-drug contraceptive measures are used in sexual life from 2 weeks before screening to 1 month after the last dose of the study drug; 3. Aged 12 to 65 years (including boundary values, whichever is the time of signing the informed consent form); 4. Agree to perform novel coronavirus nucleic acid sampling from oropharyngeal swabs only during the trial (D-1 to D7), and nasal swab sampling will not be performed; 5. SARS-CoV-2 results are positive in oropharyngeal swab samples using RT-PCR at screening (Ct value < 35), and the first positive nucleic acid test sampling time is <= 2 days from D1 administration, and the first relevant clinical symptoms <= 2 days. Note: nasal/oropharyngeal swab results before signing the informed consent; 6. Patients diagnosed with mild or usual COVID-19 according to the "Diagnosis and Treatment Plan for Novel Corona Virus Pneumonia (Trial Ninth Edition)" at screening and baseline (D-1).
Exclusion criteria
Exclusion criteria: Exclusion criteria for preventative group Subjects with any of the following exclusion criteria shall not be enrolled in the preventative administration group: 1. Patients who have or are developing diseases with clinical abnormalities that need to be excluded before screening, including but not limited to nervous/psychiatric system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases affecting drug absorption), blood and lymphatic system, urinary system, endocrine system and immune system diseases; 2. Patients with acute episodes of chronic rhinitis or anatomical anomalies affecting drug absorption in the nose; 3. Patients with a history of asthma; 4. Subjects infected with SARS-CoV-2 within 3 months prior to administration; 5. Subjects who have received any prophylactic or therapeutic agents for COVID-19, including but not limited to monoclonal antibodies against SARS-CoV-2, serum from recovered patients, antiviral agents (e.g., Paxlovid, Molnupiravir, Redesivir, Lopinavir/ritonavir combination, ribavirin, chloroquine, hydroxychloroquine and other drugs), and systemic or inhaled steroid drugs (except long-term stable dose treatment with concomitant chronic disease and no increased dose; 6. People who have a history of drug or other allergies, or who, in the judgment of the investigator, are likely to be allergic to the investigational product or any component of the investigational product; 7. Patients who had received major organ surgery (excluding puncture biopsy, tracheotomy, gastrostomy, etc.) or had significant trauma within 28 days before administration, or who needed elective surgery during the trial period; 8. Subjects who currently have acute or chronic moderate or severe liver disease, or known liver or biliary tract abnormalities (other than Gilbert syndrome or asymptomatic gallstones); 9. Subjects currently suffering from acute or chronic moderate or severe kidney disease; 10. cardiovascular disease meeting any of the following criteria: 1) history of myocardial infarction within the past 12 months; 2) unstable angina; 3) clinically significant and uncontrolled arrhythmia; 4) history of stroke or transient ischemic attack requiring medication within the past 12 months; 5) congestive heart failure based on NYHA class >= II; 6) localized edema >= grade 3 (including respiratory, thoracic and mediastinal diseases: laryngeal edema, pulmonary edema; skin and subcutaneous tissue diseases: peripheral edema); 7) clinically uncontrolled hypertension; 11.Suspected or confirmed active systemic infection, such as bacterial, fungal, viral, or other infection, or disease judged by the investigator to affect the assessment of the study endpoints; 12.Subjects with known HIV infection and positive Treponema pallidum antibody; 13.Subjects with liver disease who met any of the following: 1) known active HBV infection; 2) known HCV infection; 3) primary biliary cirrhosis; 4) moderate and severe fatty liver; 5) Child-Pugh class B or C; 6) acute liver failure; 14.Female subjects who are pregnant or lactating during the screening period; 15.Participated in other drug clinical trials and used other investigational drugs within 1 month before screening; 16.Any other condition that, in the opinion of the investigator, might affect the subject 's ability to give informed consent or to follow the trial protocol, or that the subject' s participation in the trial mig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nucleic acid test;Antigen test; | — |
Countries
China
Contacts
Public ContactGuo Jinjun, Hu Yongjun
Bishan Hosipital of Chongqing Medical university, People's Hospital of Chongqing Banan District
Outcome results
None listed