IRB Study Number 23-501
Status Recruiting
Phase Not Applicable
Location Tradition HealthPark One
Institutes Respiratory Institute, Lerner Research Institute
Description
Researchers conducting a research study to learn more about COVID-19 infection and immunity in 18-90 year olds
Inclusion Criteria
- Individuals either vaccinated or non-vaccinated, previously infected or non- infected who are between the ages of 18-90 years old will be included.
- Individuals who are able to read and understand English well enough to understand the consent process and what the study involves to make an informed decision.
- Individuals willing to provide blood and saliva samples.
Exclusion Criteria
- Those with bloodborne infectious diseases such as HIV, Hepatitis B or Hepatitis C will be excluded.
- Those who self-report having been diagnosed with anemia will be excluded.
- Those weighing less than 110 lbs. will be excluded.
- Anyone who is cognitively impaired or cannot read and understand English well enough to understand the consent process and what the study involves to make an informed decision will be excluded.
- Study team members themselves will be excluded.
- Individuals who are pregnant or become pregnant during the study will be excluded. Pregnant women participation would greatly complicate the immune analysis of this study, as we have not factored in their clinical course during their pregnancy. Since women will be in different trimesters during pregnancy, a study would have to control for due to hormonal and immunocompromised state that can occur during pregnancy. There are large immunological differences during the first trimester versus the third trimester of pregnancy which would need to be defined and reviewed for a study. In addition, this study is to collect 80mls of blood per draw that may to be adjusted for pregnant women and will have to change the use of the blood for immunological assays for women that are pregnant, since we may not be able to collect the blood volumes. Therefore, there will be a separate research study for pregnant women.
