COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=131046

Wang Fusheng

fswang302@163.com

2021-08-09

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

1. The new crown vaccine is planned, 2. Elderly subjects aged 60-80 and young and middle-aged subjects aged 18 to 59 years, 3. The subjects can and are willing to comply with the requirements of the clinical trial protocol, complete the 12-month study follow-up and sign the informed consent, 4. HBsAg, anti HCV, HIV and TPHA screening were negative, 5. The new crown RNA test was negative, 6. Axillary body temperature <=37.0 degree C.

1. Women with positive urine pregnancy test, women who are pregnant, breastfeeding, or women who plan to become pregnant within 6 months, 2. Suffering from a serious chronic disease or the disease is in a progressive stage and cannot be controlled smoothly, such as diabetes, asthma, thyroid disease, etc. that cannot be controlled by drugs, 3. Suffering from thrombocytopenia, bleeding disorders or thrombotic disorders, 4. Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc., 5. Suffering from congenital or acquired angioedema/neurotic edema, 6. History or family history of convulsions, epilepsy, encephalopathy, other progressive neurological diseases and psychiatric diseases, 7. Suffering from lymphoma, leukemia and other systemic malignant tumors, 8. Suffering from autoimmune diseases, 9. Those with fainting needles, 10. Has received immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, or inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis), 11. Received blood products within 4 months before receiving the experimental vaccine, 12. Received other research drugs within 1 month before receiving the experimental vaccine, 13. Receive other types of vaccines within 1 month before receiving the experimental vaccine, 14. Patients with acute exacerbation of chronic diseases or acute infectious diseases and fever.

1

the Fifth Medical Center of the Chinese People's Liberation Army General Hospital

18

80

China

High risk patients

N/A

300

2019 neutralizing antibody against New Coronavirus;

Not reported

[{"arm_notes": "", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]