COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=128920

Zhongming Liu

liu.zhongmin@tongji.edu.cn

2021-06-27

Recruiting

RCT

Randomized

Sequential assignment

Not reported

single-center

Prevention

1. Aged over 18 years, 2. Received two doses of the new crown inactivated vaccine at least 4 months ago, 3. According to the medical history and physical examination, the researchers judged to be healthy (excluding the following conditions: known or suspected to suffer from more serious diseases at the same time, including: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, malignant tumor, infectious disease, allergic skin disease, HIV infection (test report can be provided), 4. Those who have not been abroad in the past 2 months and have experienced outbreaks in villages/communities, who have not been in contact with people infected with the new coronavirus or suspected cases, who are in the non-isolation period, and who have not been infected with the new coronavirus in the same village/community or suspected cases, 5. Patients are willing to complete the entire study follow-up and sign the informed consent.

1. The new coronavirus antibody test is positive, and the new coronavirus nucleic acid test is positive, 2. Have a history of SARS/MERS virus infection (self-report, on-site inquiry), 3. Have been vaccinated against other novel coronavirus vaccines, 4. Those who have a history of allergy to phenol and Mamemin, 5. Women with positive urine pregnancy test, pregnant, breastfeeding, or women planning to become pregnant within 12 months, 6. Those with a medical history or family history of allergies, convulsions, epilepsy, encephalopathy and mental illness, 7. Any history of allergy to drugs or vaccinations (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioedema or abdominal pain) or allergy to known components of the new coronavirus vaccine, 8. Severe cardiovascular disease diagnosed by the hospital (cardiopulmonary failure, hypertension that cannot be controlled by drugs, etc.), 9. History of thrombocytopenia or other coagulation disorders diagnosed by the hospital, 10. Those who have received whole blood, plasma and immunoglobulin therapy within 3 months, 11. Patients with clinically significant abnormalities in blood biochemistry, blood routine, and urine routine related indexes detected before vaccination in Phase I clinical study, 12. Those with symptoms of fever (axillary temperature>37.3?), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before vaccination, 13. Received live attenuated vaccine within 1 month before vaccination, and received other vaccines within 14 days before vaccination, 14. Those with axillary body temperature >37.3? during vaccination, 15. Contraindications related to vaccination in the opinion of the investigator.

2

Shanghai East Hospital

18

100

China

Healthy volunteers

N/A

20

adverse events;adverse reactions;

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

Phase 1

[{"arm_notes": "No information on dose", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "No information on dose", "treatment_id": 401, "treatment_name": "Df104b1", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]