COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=122756

Zhongming Liu

liu.zhongmin@tongji.edu.cn

2021-03-05

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Prevention

1. Request medical history and physical examination, and the researchers judged health status of subjects, 2. Aged 18 to 60 years, 3. BMI 18.5-30Kg/m2, 4. Novel Coronavirus (COVID-19) antibodies (IgG, IgM) are negative, 5. Female subjects with childbearing age are not pregnant at the time of admission (negative reaction in urine pregnancy test), 6. Armpit temperature <=37 degree C, 7. The Subjects are able to comply with the study and sign the informed consent voluntarily.

1. Subjects with history of convulsion, epilepsy, Guillain Barre syndrome, encephalopathy or mental illness or family history, 2. Fever (armpit temperature > 37.0 degree C) before vaccination, 3. Subjects with history of severe allergic reactions (such as anaphylactic shock, acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of vaccine, 4. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, malignant tumors, 5. Subjects with various acute diseases, uncontrollable severe chronic disease, acute onset of chronic diseases or fever, 6. Subjects with abnormal indicators, such as blood biochemistry, blood routine and urine routine, which might show clinical meaning, before administration, 7. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 8. Female Subjects in pregnancy, lactation or have a family planning within 3 months, 9. Subjects receiving the immunosuppressive therapy, glucocorticoids, antiallergic or cytotoxic therapy within 6 months, 10. Subjects vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination, 11. Subjects receiving blood products within 3 months before administration, 12. Subjects receiving other research drugs within 6 months before vaccination, 13. The researchers shall judge the other conditions which might be not in compliance with the reequipments of this clinical trial.

2

Shanghai Oriental Hospital

18

60

China

Healthy volunteers

N/A

16

neutralizing antibody;specific antibody;adverse events;Adverse reactions;blood biochemistry;blood routine;Coagulation function index;urine routine;HbA1c;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

[{"arm_notes": "No information on dosage", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "No information on dosage", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]