COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=62581

Professeur Abouqal Redouane

rabouqal@gmail.com

2020-10-13

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Age range: healthy people aged 18 and above, 2. Medical history and physical examination were inquired, and the researcher judged that he was in good health, 3. Female subjects of childbearing age were not pregnant (negative urine pregnancy test), were not in lactation and had no family planning in the first 3 months after enrollment, effective contraceptive measures were taken in the first 2 weeks before enrollment, 4. The subjects who are able and willing to complete the whole research plan during the whole follow-up period, 5. The subjects have the ability to understand the research procedure, and voluntarily sign the informed consent after informed consent, and can comply with the requirements of the clinical research protocol.

1. Novel coronavirus infection confirmed cases, 2. History of SARS and mers infection (self report, on-site inquiry), 3. Fever (axillary temperature > 37.0 degrees C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before inoculation, 4. The axillary temperature was more than 37.0 degrees C before inoculation, 5. Novel coronavirus inactivated vaccine has been sensitization to severe allergic reactions (such as acute allergic reaction, urticaria, eczema, dyspnea, neurovascular edema or abdominal pain). 6. History of convulsion, epilepsy, encephalopathy or mental illness or family history, 7. Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc, 8. Severe liver and kidney diseases, drug uncontrollable hypertension (systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg), diabetic complications, malignant tumor, acute attack of various acute or chronic diseases, 9. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 10. Known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors, 11. History of coagulation dysfunction (such as coagulation factor deficiency, coagulation diseases), 12. Receiving anti TB treatment, 13. Those who received immunoenhancement or immunosuppressive therapy within 3 months (continued oral or drip for more than 14 days), 14. Vaccinated with live attenuated vaccine within one month before vaccination and other vaccines within 14 days before vaccination, 15. Received blood products within 3 months before vaccination, 16. Received other research drugs within 6 months before vaccination, 17. The researcher judged other situations not suitable to participate in this clinical trial, 18. Severe allergic reaction and high fever (axillary temperature >= 39.0 degrees C) lasting for three days after the previous dose of vaccination, 19. Serious adverse reactions related to the previous dose of vaccination, 20. Reach the end of the study, 21. The researcher shall decide whether to continue to participate in the study if the new discovery or occurrence after the previous dose of vaccine does not meet the inclusion criteria of the first dose or meets the exclusion criteria of the first dose, 22. Other exclusion reasons considered by researchers, 23. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial: -Non specific immunoglobulins were used during the study, -Continuous oral or drip steroid hormone for 14 days. 24. Items 18-23 above are the exclusion criteria for the second dose.

2

China National Biotec Group Co.Ltd

18

100

Morocco

Healthy volunteers

N/A

600

To evaluate the 4-fold increase rate; GMT and GMI of anti-SARS-CoV-2 neutralizing antibody 28 days after full course of immunization;

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

Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1 or 2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]