COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=53003

Yanxia Wang

wangyanxia99@163.com

2020-04-29

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

1. Healthy subjects aged 3 years and above, 2. By asking for a medical history and a physical examination, the researchers determined that the subjects were in good health, 3. From December 2019 to now, the subject has not been to hubei province, outside the country or in a village/community where there has been an outbreak. The subject has not been exposed to a person infected with or suspected of COVID-19, 4. Female subjects with childbearing age are not pregnant at the time of admission (negative reaction in urine pregnancy test), and are not nursing and have not fertility plan within the first 3 months after admission. Effective contraceptive measures shall be taken within 2 weeks before inclusion, 5. Subjects are able and willing to complete the study plan over follow-up period of approximately 14 months, 6. The subject or/and his/her legal guardian or trustee have the ability to understand the study procedures, voluntarily sign informed consent with informed consent, and comply with the requirements of the clinical study protocol.

1. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control), 2. Positive in serum antibodies (IgG and IgM) screening of COVID-19, 3. Has a history of SARS virus infection (self-reported, site information), 4. Fever (armpit temperature > 37.0 degree C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before administration, 5. Subjects with abnormal indicators, such as blood biochemistry, blood routine and urine routine, which might show clinical meaning, before administration (only refers to Phase I), 6. Armpit temperature > 37.0 degree C before administration, 7. History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of COVID-19 vaccine, 8. History of convulsion, epilepsy, encephalopathy or mental illness or family history, 9. with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., 10. with severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >=90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases, 11. diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 12. with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, malignant tumors, 13. with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease), 14. Receiving anti-TB treatment, 15. Receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days), 16. vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination, 17. Receiving blood products within 3 months before administration, 18. Receiving other research drugs within 6 months before vaccination, 19. The investigators determined that other conditions were inappropriate for the study.

4

Henan Provincial Center for Disease Control and Prevention

3

100

China

Healthy volunteers

N/A

1500

Incidence of adverse reactions/events;

Phase 1/Phase 2

[{"arm_notes": "3", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "low dose;3", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "medium dose;3", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "high dose;3", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]