Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
DC injection:COVID19 s-vax loaded autologous dendritic cell injection
Sponsors
Beijing TIL Therapeutics
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. volunteers between 18 and 60 years old; 2. be able to understand and sign informed consent form; 3. agree to collect blood samples during the study and follow-up; 4. blood test results: Hemoglobin= 110 g/L, White blood cell (WBC) >=4x10^9/L, absolute neutrophil count (ANC)>=2x10^9/L, monocyte>=0.2x10^9/L, PLT>=100x10^9/L; 5. ECOG(Eastern Cooperative Oncology Group)score 0 or 1; 6. blood biochemistry results: alanine aminotransferase (ALT) < 40 IU/L, aspartate aminotransferase (AST) < 45 IU/L; 7. women of reproductive potential must have a negative pregnancy test and agree to take effective birth control within one year during the study; 8. male participants agree to practice birth control within one year during the study.
Exclusion criteria
Exclusion criteria: 1. allergic, persons who had a history of allergy to vaccine or seriouse reaction, such as Hypersensitivity, systemic urticaria, blood vessel edema, or other obviously reaction, or are allergy to two or more drugs or food; 2. persons who are under chemotherapy or have conformed cancers; 3. persons who are infected with HIV, HBV, HCV or COVID-19; 4. persons who have active infection that need systemic treatment, such as systemic fugus infection, bacterial infection, viral infection or other infection; 5. fever with body temperature >37.2°C during screening or before first DC injection; 6. prior history of drug abuse or psychological disease that may affect follow the study requirements; 7. in opinions of investigators, persons have abnormal results of blood test, blood biochemical test or viral test; 8. persons who has received a live vaccine within 30 days of the first DC injection; Note: seasonal inactivated flu shot within 30 days of first DC injection is allowed, but attenuated in-nose live flu shot is not allowed. 9. in opinions of investigator, persons may not be eligible or are not able to comply with the study, who have a prior history of disease, receiving certain kind of treatment, abnormal results, or other concerns; 10. active autoimmune disease patients such as SLE, who need systemic treatment, such as Systemic corticosteroid therapy or immunosuppressive drugs within two years of first DC injection. Replace therapy is not considered as systemic treatment, such as Thyroid hormones, Insulin, or physiological Corticosteroid therapy for patients with decreased Adrenal Gland or pituitary gland functions; 11. pregnant or breast-feeding women 12. persons refuse to practice birth control within one year during study and follow-up; 13. persons who have disease, such as uncontrolled neurological or psychological disease, immune dysregulated disease, metabolism disease, infectious disease, or received therapeutic surgery, that investigator concern that may affect acomplish the study, including DC injection, follow-up or evaluation; 14. persons have severe defects in heart and lung functions, such as uncontrolled high blood pressure, unstable coronary artery vessel disease (such as uncontrolled cardiac arrhythmia, or unstable angina pectoris), congestive heart failure, myocardial infarction within 6 months of enrollment; 15. persons participate other clinical trials and have received study drugs or instruments three months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| the seroconversion rate of anti-COVID19 S-protein after DC injection; | — |
Countries
China
Contacts
Public ContactXiaoyu Xiang
Beijing TIL Therapeutics
Outcome results
None listed