Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 60 and above with full capacity for civil conduct; 2. Chronic bronchitis research subjects: diagnosed with chronic bronchitis by first-level and above medical institutions; chronic obstructive pulmonary disease research subjects: diagnosed with chronic obstructive pulmonary disease by first-level and above medical institutions; 3. Axillary temperature < 37.3 degree C confirmed by clinical examination before entering this study; 4. Able and willing to complete the entire research plan during the entire study follow-up period; 5. The patients have the ability to understand the research procedures, sign the informed consent form voluntarily after informed consent, and be able to comply with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1. The subject has previously been a confirmed case of the new crown or asymptomatic infection; 2. The subject has a history of new coronavirus vaccination; 3. Those who are known to be allergic to any ingredients (including excipients) contained in this product; 4. Injection of non-specific immunoglobulin within 1 month before enrollment; 5. Have been vaccinated with live attenuated vaccine within 1 month before vaccination, and have received other vaccines within 14 days before vaccination; 6. Those who have experienced severe allergic reactions to vaccines in the past (such as acute allergic reactions, urticaria, angioedema, dyspnea, etc.); 7. Those with uncontrolled epilepsy and other progressive neurological diseases, those with a history of Guillain-Barré syndrome; 8. Severe liver and kidney diseases, malignant tumors, various acute diseases or acute exacerbations of chronic diseases; 9. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 10. A history of clearly diagnosed thrombocytopenia or other coagulation disorders, which may cause subcutaneous injections to be contraindicated; 11. During acute exacerbation of chronic bronchitis/chronic obstructive pulmonary disease; 12. Other subjects whose physical conditions are deemed unsuitable for inclusion in clinical research by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Novel coronavirus antibody 4 times growth rate and antibody level (GMT, GMI);Incidence of adverse reactions/events;Incidence of serious adverse events (SAEs); | — |
Countries
China
Contacts
Hubei Provincial Center for Disease Control and Prevention