Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
group A :Recombinant COVID-19 vaccine (CHO cell)
group B :COVID-19 inactivated vaccine (Vero cell)
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with COVID-19 diagnosed in accordance with the "COVID-19 Diagnosis and Treatment Plan (Trial Eighth Revised Edition)" formulated by the National Health Commission of the People's Republic of China or those who are asymptomatically infected with COVID-19 diagnosed in accordance with the "COVID-19 Prevention and Control Plan (Eighth Edition)"; 2. The age of the subject is 18 to 65 years old (including 18 and 65 years old), and there is no limit to men and women; 3. Respiratory tract samples of confirmed patients with COVID-19 and asymptomatic infections of COVID-19 still tested positive 4 weeks after the first nucleic acid positive.And within 24 hours before screening, any samples confirmed by the laboratory were positive for SARS-CoV-2; 4. The patient's clinical condition is stable, there are no new exudative lesions in chest imaging, and peripheral blood inflammation indicators are normal (such as C-reactive protein, erythrocyte sedimentation rate, serum amyloid A, procalcitonin, etc.); 5. Before enrollment, COVID-19 antibody IgM < 50S/CO and IgG < 50S/CO; 6. Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures within 6 months after signing the informed consent form to the study drug administration; 7. The subject agrees to collect nasopharyngeal swabs, sputum and venous blood; 8. The subject can communicate well with the researcher, understand and comply with the requirements of this research, understand and sign the ICF.
Exclusion criteria
Exclusion criteria: 1. The patient's clinical data is incomplete. 2. The investigator believes that any serious concomitant systemic diseases, conditions or obstacles should be prevented from participating in this study: (1) Have a history of grade III-IV heart failure as defined by the New York Heart Association (NYHA), or a known left ventricular ejection fraction is 160 mmHg and/or DBP is > 100 mmHg in sitting position at screening/baseline; (5) Cerebral thromboembolism, deep vein thrombosis or pulmonary embolism; (6) Suspected or confirmed serious, active bacteria, fungi, viruses or other infections; (7) Have a history of chronic obstructive pulmonary disease or bronchial asthma; (8) Have type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes within 6 months before screening (HbA1c > 9.0%); (9) With active liver disease or liver dysfunction, the ALT or AST level at screening is > 3 times the upper limit of the normal range; (10) With moderate to severe renal insufficiency, eGFR <= 50ml/min/1.73 m2 at the time of screening; (11) Have a history of transplantation of important organs (such as heart, lung, liver, kidney, etc.); (12) Suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); (13) Suffering from systemic or local autoimmune or inflammatory diseases; (14) Have undergone any major surgery within 3 months before screening: subjects with gastrointestinal perforation, gastrointestinal fistula, abdominal abscess and internal fistula before screening; Subjects with unhealed wounds, active gastric ulcers or fractures; (15) Subjects with hemoptysis, gastrointestinal bleeding, central nervous system bleeding, epistaxis and other severe or active bleeding within 1 month before screening; (16) Patients with hereditary bleeding tendency or coagulation dysfunction; (17) Patients with human immunodeficiency virus (HIV) infection; 3. Those who have been vaccinated against COVID-19 within 3 months before screening; 4. Those who have received SARS-CoV-2 specific monoclonal antibody treatment or have received the history of convalescent COVID-19 plasma treatment; 5. The therapeutic biological agent has been used within 3 months before screening, or the drug is in the elimination period (5 half-life periods) at the time of random administration;Participated in any other clinical studies with investigational drug intervention within 1 month before screening, or the investigational drug is still within the elimination period (5 half-lives) when administered randomly; 6. Those who have had a severe allergic reaction or hypersensitivity to food, drugs, other vaccines and related ingredients in the past, or those with allergies; 7. The auxiliary examination results are obviously abnormal during screening, such as: (1) Pl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| nucleic acid negative conversion time;nucleic acid negative conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody IgM, IgG levels;The neutralizing antibody S, N, total antibody;Memory B cell ratio;Imaging examination;electrocardiogram;Lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactChen Zhihai
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed