Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Case series: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. Aged 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 period; 4. Blood test satisfy: Hemoglobin>=110 g/LWhite blood cell >=4x10^9/L, absolute neutrophil count >=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: alanine aminotransferase (ALT) < 40 IU/Laspartate 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 severe 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. 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 principal investigator, participant has 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 inactive 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 principal investigator, participants 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 finish the study, including DC injection, follow-up or evaluation; 14. Persons have severe defects in heart and lung functions: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| seroconversion rate anti-COVID19 S-protein after DC injection; | — |
Countries
China
Contacts
Public ContactShengjun Ma
Liaocheng People's Hospital
Outcome results
None listed