COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=135214

Ronghua Jin

93353503@qq.com

2021-10-12

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

1.Adult subjects (18 years old), no gender limitation, 2.Subjects in good health or stable clinical situation, 3.Subjects who completed two doses of inactivated COVID-19 vaccine 4-8 months ago, 4.Female subjects of childbearing age are not breast-feeding or pregnant (negative blood pregnancy test), and have no family planning in the first 3 months after enrollment. Take effective contraceptive measures within 2 weeks before enrollment, 5.Participant is willing and able to adhere to the procedures specified in this protocol, 6.Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.

The participant may not enter the trial if ANY of the following apply: 1.SARS-CoV-2 infection confirmed by RT-qPCR detection, 2.Clinical manifestations including fever, dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, dyspnea, etc., 3.Body temperature >37.0 degree C before vaccination, 4.Urine pregnancy test positive, 5.Severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioedema or abdominal pain) or allergic to the known ingredients of the inactivated SARS-CoV-2 vaccine, 6.History or family history of convulsions, epilepsy, encephalopathy or mental illness, 7.Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. 8.Suffer from severe liver and kidney disease, uncontrollable hypertension (systolic blood pressure>=140 mmHg, diastolic blood pressure>=90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attacks of chronic diseases, 9.Diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 10.Are receiving anti-tuberculosis treatment, 11.Known or suspected diseases include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases and malignant tumors, 12.History of coagulation dysfunction (such as coagulation factor deficiency, coagulation disease), 13.Receipt of immunotherapy or inhibitor treatment within 3 months (continuous oral or infusion for more than 14 days), 14.Receipt of any live attenuated vaccine within 1 month before this vaccination, and other vaccines within 14 days before this vaccination, 15.Receipt of other study drugs within 6 months before vaccination, 16.The investigator judged that it is not suitable for other situations in this clinical trial.

3

Beijing Ditan Hospital; Capital Medical University

18

100

China

Healthy volunteers

N/A

200

The incidence of effective immune reactivation on the 14th day of enrollment (Geometric mean titers (GMTs) of neutralizing antibodies produced in response to SARS-CoV-2 live virus increased 4 times or more from baseline; or changed from negative to positive from baseline);

| Declared number of arm (3.0) differs from found arms (4.0)

Not reported

[{"arm_notes": "", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1154, "treatment_name": "Sars-cov-2 recombinant protein vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]