COVID-19
Conditions
Interventions
Vaccine induced plasma group:Clinical blood users were transfused with plasma containing high titers of neutralizing antibodies to COVID-19 induced by vaccination
Normal plasma group:Clinical blood users were transfused with plasma from healthy persons (unvaccinated/uninfected, vaccinated/infected for more than 6 months) which does not contain high titers of ne
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Blood donor inclusion criteria: voluntary whole blood donation; Weight greater than or equal to 50kg; BMI 18.5-30.0; Armpit body temperature =37.0?; HIV, hepatitis B, hepatitis C, syphilis screening negative; The RT-PCR test of throat swab was negative for COVID-19. Have received the COVID-19 vaccine sequential immunization booster more than 14 days and less than or equal to 3 months since the last vaccination; Have been infected with COVID-19 for at least 1 month since the last infection; The antibody titer in plasma was greater than or equal to 1:40; Participants fully understand the purpose, nature, and method of the experiment and voluntarily give informed consent. Inclusion criteria for blood users: weight greater than or equal to 50kg; BMI 18.5-30.0; Armpit body temperature =37.0?; HIV, hepatitis B, hepatitis C, syphilis screening negative; The real-time quantitative fluorescent PCR of throat swabs tested negative for COVID-19. Blood routine, blood biochemistry and other laboratory examination indicators were in the normal range (patients with blood were selected from infectious departments and artificial liver patients, and such people only needed plasma infusion for treatment, which increased the comparability of test subjects and ensured stable baseline blood routine and biochemical levels); At least 6 months since the last vaccination; At least 6 months since the last COVID-19 infection; The antibody titer in plasma is less than or equal to 1:40; Only one blood transfusion within 30 days after participating in the program; Participants fully understood the purpose, nature, and method of the experiment and voluntarily gave informed consent and participated in regular follow-up.
Exclusion criteria
Exclusion criteria: Blood donor exclusion criteria: age below 18 years old or above 60 years old; Pregnant women; Use antibiotics within 48 hours before blood donation; Taking immunological drugs; Immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months; HIV virus, hepatitis B virus, hepatitis C virus, syphilis virus infection history; medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent. Blood user exclusion criteria: age below 18 years old or above 60 years old; Pregnant women; Use antibiotics within 48 hours before blood donation; Taking immunological drugs; Total plasma protein level < 6.0g/dL; Have a history of severe allergic reactions or allergies; Immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months; HIV virus, hepatitis B virus, hepatitis C virus, syphilis virus infection history; Received blood products within 4 months prior to receiving plasma transfusion; (b) medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NAb titer against SARS-CoV-2; | — |
Secondary
| Measure | Time frame |
|---|---|
| IgG titer against SARS-CoV-2;IFN- ? TNF and IL-2 cytokine levels; | — |
Countries
China
Contacts
Public ContactYuxiao Wang
Jiangsu Provincial People's Hospital
Outcome results
None listed