COVID-19 ANTIBODY monitoring
Research type
Research Study
Full title
Measurement of quantitative COVID-19 Ab levels in participants for up to 18 months following PCR positive test; additionally a single measurement of quantitative COVID-19 Ab levels in participants who are PCR negative/not tested to look for background infection rates.
IRAS ID
289400
Contact name
William Garry John
Contact email
Sponsor organisation
Norfolk and Norwich University Hospital
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
There is limited data regarding exactly how antibody levels (IgG and IgM) change with time following infection with COVID-19; but there is developing evidence that COVID-19 antibodies may decline with time. It is not known how long the time period of decline is for individuals, or the range of time period for a group of individuals.
Antibody measurements (IgG) will be made monthly on 15 mL blood samples collected from participants for up to 18 months or until antibody levels are no longer measurable if less than 18 months. Depending on time from PCR testing to firs sample IgM antibodies may also be measured; typically IgM antibodies become unmeasurable in weeks. Samples will be collected be a trained phlebotomist.
The purpose of this research is to establish a range of values for COVID-19 antibodies found in individuals following infection, and monitor the rate of decline over time using quantitative antibody methods.
This research will be important to assess the length of time an individual retains antibodies after an infection, and is therefore assumed to be immune to COVID-19; secondly to assess immune status after vaccination.
Subjects will also complete a small questionnaire providing data which will be limited to basic demographics and symptoms of COVID-19 they experienced.
Potential participants will be excluded if they are immunosuppressed or have any other disease which may affect their antibody levels
We also intend to screen 100 individuals who have not been tested for COVID-19 or have tested negative to investigate local background infection. These participants will be anonymised and will only undergo a single 15mL blood sample.
Additional biochemical measurements (eg Vitamin D) will be made on samples (or stored samples) if during the course of the study there becomes a proven scientific reason to do so.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0268
Date of REC Opinion
16 Nov 2020
REC opinion
Unfavourable Opinion