COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05382871

Ivan Hung

Not reported

2022-05-19

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: age range: populations aged 18 years and above. judged by the investigator that the health condition is well after inquiry and physical examination. vaccinated with 2 doses/3 doses of inactivated covid-19 vaccine or mrna vaccine for ≥ 3 months. female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 7 months after enrollment. effective contraceptive measures have been taken within 2 weeks before inclusion. during the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. with self ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.

confirmed cases, suspected cases or asymptomatic cases of covid-19; with a history of severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers) (self-report, on-site inquiry); has vaccinated with one or four doses and above covid-19 vaccine; axillary temperature ≥37.3℃ (tympanic temperature ≥ 37.6 ℃); previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of covid-19 vaccine (self-report, onsite enquiry); have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry); with known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry); have an uncontrolled epilepsy and other progressive neurological diseases or a history of guillain-barre syndrome (self-report, onsite enquiry); received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry); known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, human immunodeficiency virus (hiv) infection (self-report, onsite enquiry, provide test report if available); with hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥ 140 mmhg and/or diastolic blood pressure ≥ 90 mmhg), acute attacks of chronic respiratory illness (self-report, onsite enquiry); received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry); received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry); participating or planning to participate in other interventional vaccine clinical trials during this study other vaccination-related contraindications considered by investigators.

6

China National Biotec Group Company Limited

18

100

Hong Kong

Healthy volunteers

N/A

1804

The 4-fold rise rate of anti-omicron neutralizing antibody;The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody

None

Phase 3

[{"arm_notes": "after 2 or 3 doses of inactivated COVID-19 vaccine", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 2 or 3 doses of inactivated COVID-19 vaccine", "treatment_id": 2493, "treatment_name": "Wipb", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 2 or 3 doses of COVID-19 mRNA vaccine", "treatment_id": 2493, "treatment_name": "Wipb", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 2 or 3 doses of COVID-19 mRNA vaccine", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 2 or 3 doses of inactivated COVID-19 vaccine", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 2 or 3 doses of COVID-19 mRNA vaccine", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]