Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old and sign the informed consent form; 2. It was confirmed as COVID-19 infection by etiological and serological examination, which led to hospitalization or severe disease; 3. The chest imaging showed the characteristic manifestations of COVID-19 pneumonia; 4. Subjects agree and are willing to be randomly assigned to any treatment group; 5. The subject agreed not to participate in any other drug study under study before the 28th day of completion of the study; 6. Subjects can and are willing to comply with the requirements of the clinical trial protocol, and can complete 12 months of study follow-up; 7. Men and women of childbearing age who are fertile voluntarily use effective contraceptives from the signing of the love letter to three months after the completion of vaccination, including abstinence or effective contraceptives (such as intrauterine or implanted contraceptive devices, oral contraceptives, injection or embedded contraceptives, slow-release local contraceptives, intrauterine devices (IUDs), condoms (men), diaphragms, cervical caps, etc.).
Exclusion criteria
Exclusion criteria: 1. The doctor believes that participating in this study is not in the best interests of the subject, or is contrary to the test plan due to various medical, psychological, social or other conditions, or there are any circumstances that can not guarantee the safe implementation of this study plan; 2. Those who are allergic to any component in the study vaccine, have a relatively serious vaccine allergy reaction, drug allergy history or asthma, urticaria history in the past; 3. Serious adverse reactions related to the vaccination occurred after the previous vaccination of COVID-19 vaccine; 4. Have a history of convulsion, epilepsy, encephalopathy, psychosis or family history; 5. Serious cardio-cerebrovascular diseases (myocardial infarction, grade 3 hypertension, cerebral infarction, etc.); 6. Patients with known severe renal insufficiency (estimated glomerular filtration rate = 30mL/min/1.73m2) or undergoing continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 7. Have serious liver disease (such as Child Pugh score = grade C, AST more than 5 times the upper normal limit); 8. No spleen or functional no spleen; 9. Women are in pregnancy or lactation, or plan to become pregnant or donate eggs during the experiment; 10. According to the judgment of the researcher, due to various medical, psychological, social or other conditions, it is contrary to the test plan or affects the subject to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse reactions (AR) within 14 days after the first dose to the second dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events (AE) within 14 days after the first dose to the second dose;Incidence rate of adverse events (AE) within 1 month after the first dose to the second dose;Proportion of unexpected adverse events within 1 month after the first dose to the second dose;Proportion of unexpected adverse events (1-34 days);Severity of symptoms/signs of each COVID-19 (1-28 days);Mortality (1-24 weeks);RT-PCR titer of oropharyngeal and nasal swab virus (1-14 days);COVID-19 treatment hospitalization and intensive care unit days (1-34 days);The geometric mean titer (GMT), positive conversion rate (SCR) and geometric mean growth factor (GMFI) of the anti-SARS-CoV-2 specific neutralizing antibody before the second dose, on the 14th and 21st days after inoculation;The geometric mean titer (GMT), positive conversion rate (SCR) and geometric mean growth factor (GMFI) of the anti-SARS-CoV-2 binding antibody before the second dose, on the 14th and 21st days after inoculation; | — |
Countries
China
Contacts
Public ContactWeimin Li
West China Hospital, Sichuan University
Outcome results
None listed