COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=133228

Huang Ting

cocoht@163.com

2021-09-05

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Subjects aged 18 years and older, 2. Subjects capable of understanding and voluntarily signing the informed consent, 3. Subjects with general good health as judged by medical history and physical examination. General good health was defined as no significant change of treatment or hospitalization due to disease deterioration within 3 months prior to enrollment, 4. Women of childbearing age presented with a negative pregnancy test result prior to vaccination, and who voluntarily agree to take effective contraceptive measures (including: oral contraceptives (excluding emergency contraceptives), injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.) from the time of signing the informed consent until the end of the study.

1. History of COVID-19, or positive results for either SARS-CoV-2 nucleic acid and antibody tests at screening (outside China only), 2. Suspected or confirmed fever (axillary temperature >= 37.3 degrees/oral temperature >= 37.5 degrees) within 72 hours prior to or on the day of enrollment, 3. History of human coronavirus infection/diseases, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), 4. Any confirmed or suspected immunosuppression or immunodeficiency status, known history of HIV infection, absence or functional absence of spleen caused by any condition, 5. Presence of severe, uncontrollable or hospitalized cardiovascular diseases, diabetes, neurological diseases (e.g., Green-Barry syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases (e.g., active tuberculosis, pulmonary fibrosis), metabolic and skeletal diseases, or malignant tumors, 6. Any acute diseases or acute attacks of chronic diseases 3 days prior to enrollment, 7. Genetic predisposition of bleeding, or history of coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage, 8. History of severe allergy to drugs and vaccines, or to any component of the test vaccine (including the aluminum adjuvant), such as anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, dyspnea, angioneurotic edema, etc., 9. Receipt of any SARS-COV-2 vaccine (including conditional approved/emergency use authorized vaccines or experimental vaccines), 10. Receipt of immunoglobulin and/or other blood products within 3 months prior to vaccination, 11. Receipt of live attenuated vaccine within 28 days prior to vaccination and other vaccines within 14 days prior to vaccination, 12. Previously or currently participation of any other COVID-19 prophylactic drug trials during the study (if subjects underwent hospitalization owning to COVID-19, participation in a treatment trial is permitted, but should notify the investigators immediately), 13. Long-term receipt (> 14 consecutive days) of glucocorticoid (reference value for dose: >= 20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical corticosteroids, or short-term use (<= 14 consecutive days) of oral corticosteroids, 14. Lactating females, 15. Suspected or known history of severe alcohol (alcoholism) or drug dependence, 16. History or family history of psychiatric illness that may affect trial outcomes, 17. Planned permanent relocation from the study sites during the study or prolonged absence from the local area (affecting the scheduled visit time) during the study visits, 18. Other circumstances which the investigator considers inappropriate for participating in the trial.

3

Sichuan Center for Disease Control and Prevention

18

100

China

Healthy volunteers

N/A

14600

Protective efficacy of symptomatic; virologically confirmed (RT-PCR positive) COVID-19 cases (efficacy endpoint);The incidence of adverse events (AE) (safety endpoint);

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

Phase 3

[{"arm_notes": "", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "China cohort, for immunogenicity bridging", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]