N/A
N=28,411
Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies
Solid Organ Transplant Recipients · Autoimmune Diseases · Haematological Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT05148806 ↗Enrolled (actual)
28,411
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: The Proportion of Participants With and Without Antibodies to SARS-CoV-2 — 875; 378; 277; 1825 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- self-administered lateral flow assays (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants With and Without Antibodies to SARS-CoV-2 |
1242; 507; 1006; 4804; 3024; 3651 | — |
| PRIMARY The Proportion of Participants With and Without Antibodies to SARS-CoV-2 |
1242; 507; 1006; 4804; 3024; 3651 | — |
| PRIMARY The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period After 3rd or 4th Vaccine |
— | — |
| PRIMARY The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19 |
— | — |
| PRIMARY Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine |
875; 378; 277; 1825; 2237; 991 | — |
Summary
DESIGN Observational epidemiological study
AIMS - To determine:
1. The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status.
2. If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.
Eligibility Criteria
Inclusion Criteria
Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:
- A solid organ transplant recipient (n=12,000)
- Patients with a rare autoimmune disease (n=12,000)
- Patients with lymphoid malignancies (n=12,000) -
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT05148806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.