COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=126046

Lanjuan Li

chenguiling707@126.com

2021-05-01

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

1. Chinese aged 18 or above who can provide legal proof of identity, 2. According to the medical history and physical examination, the researcher determined that the patient was healthy, both male and female, 3. Having the ability to understand the study procedures, have informed consent, voluntarily signed informed consent, can comply with the requirements of the clinical study protocol, having the ability to use the thermometer, scale and fill in the diary card and contact card as required.

1. Have been diagnosed with a COVID-19 case or suspected case, had contact with a confirmed or suspected case of Novel Coronavirus within one month before signing the informed consent, or have traveled to areas with high epidemic incidence or abroad, Or novel coronavirus infection or carrier: serum anti-SARS-CoV-2 specific antibody positive, or nasopharyngeal swab specimens SARS-CoV-2 nucleic acid positive, 2. Patients with HBV surface antigen characterization, hepatitis C virus core antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody detection positive, 3. Have a history of SARS/MERS virus infection (self-report, on-site inquiry), 4. Have received other Novel Coronavirus vaccines, 5. Have a history of allergy to acetaminophen, 6. Female with positive blood pregnancy test, pregnant or lactating, or female who plans to become pregnant within 14 months, or male whose partner plans to become pregnant, 7. Patients with a history or family history of allergies, convulsions, epilepsy, encephalopathy and mental illness, 8. Previous allergic history of any drug or vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema, or abdominal pain) or allergy to known components of Novel Coronavirus vaccine, 9. A history of thrombocytopenia or other coagulation disorders diagnosed in the hospital, 10. Patients with known immunological impairment or low function diagnosed by hospital, 11. Patients who have received whole blood, plasma and immunoglobulin treatment within 3 months, who have donated or lost blood within 3 months (=450ml), or who plan to donate blood during the trial, 12. In clinical studies, abnormal blood biochemical, blood routine and urine routine indexes were detected before inoculation, which had clinical significance, 13. Patients with fever (armpit temperature >= 37.3 degree C), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, tachypnea, dyspnea within 14 days before inoculation, 14. Have received live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination, 15. Armpit temperature >= 37.3 degree C at the time of inoculation, 16. Immunosuppressive therapy within 6 months prior to signing the informed consent, such as long-term systemic glucocorticoid therapy (systemic glucocorticoid therapy, such as prednisone or similar drugs, for more than 2 consecutive weeks within 6 months), but topical medication (such as ointment, eye drops, inhalants or nasal sprays) is allowed. Topical medication should not exceed the recommended dose in the instructions or there are any signs of systemic exposure, 17. Patients with a history of diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolic system and skeletal system or malignant tumors (excluding chronic history with stable control, such as diabetes, hypertension, etc.), 18. Contradictions considered by the investigator to be associated with vaccination. 19. Any investigational or unregistered product (drug, vaccine, biological product or device) other than the study vaccine was used or planned to be used during the study period during the 3 months prior to signing the informed consent.

9

shulan (Hangzhou) Hospital

18

100

China

Healthy volunteers

N/A

240

Security Index;Security Index;

| Declared number of arm (8.0) differs from found arms (9.0)

Phase 1

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