COV-AD: COVID infection in patients with antibody deficiency [COVID-19]
COV-AD: COVID infection in patients with antibody deficiency
University of Birmingham
Duration of Study in the UK
1 years, 6 months, 1 days
Our national case series identified that individuals with immunodeficiency are more likely to develop severe COVID-19. Concern has also been raised that the virus itself can mutate more rapidly in individuals with impaired immunity, presenting a potential public health risk. Understanding the immune response following COVID-19 infection and vaccination in individuals with immune deficiency and their response to vaccination is of the upmost importance.
The multicentre study will have three arms: the first arm will recruit 50 individuals who have previously tested positive for COVID-19 and investigate whether they continue to carry the virus and the quality of their immune responses through a single blood test. The second arm will recruit 1000 individuals who have never had symptoms of COVID-19; this group of individuals will be invited to submit a swab and a finger-prick blood sample to test for antibodies, allowing us to estimate the prevalence of asymptomatic infection in immune deficient individuals. This group will also be monitored for their antibody response to routine COVID-19 vaccination. This will be done through home testing with a finger-prick blood spot at 1 and 6 months after their vaccination. A subgroup of 200 participants will provide a peripheral blood sample so the immune response to vaccination can be studied in more detail. The third arm will investigate 400 patients who report symptoms of COVID-19 during the study period; these individuals will have a viral swab and if that result is positive, serial viral swabs will be undertaken to understand whether individuals with immune deficiency carry the virus for prolonged periods of time. As mild COVID-19 mimics many other mild chest infections, this group of individuals will also allow us to understand how COVID-19 manifests in individuals with immune deficiency and an estimate of vaccine efficacy in this at risk group.
Arm 3 will include 400 patients who develop symptoms consistent with COVID-19 during the study, having previously been enrolled in either Arm 1 or Arm 2. If they have a positive swab for SARS-CoV-2, they will have 2 weekly swabs until they swab negative. Blood testing will examine their response to natural infection. If there is no detectable humoral or cellular response at 1 month then no further bloods will be undertaken. If there is some immune response, the longevity of this response will be measured with blood tests at 6 months. If their PCR swab test is negative, they will have no further swabs and will return to arm 2. Those patients that become COVID-19 symptomatic or receive the vaccination will continue with swab testing.
London - Dulwich Research Ethics Committee
Date of REC Opinion
22 Feb 2021
Further Information Favourable Opinion