Evaluation of Point-of-Care (EPOC)
Research type
Research Study
Full title
Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
IRAS ID
311393
Contact name
Sarah Pett
Contact email
Sponsor organisation
Regents of the University of Minnesota
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
SARS-CoV-2, the coronavirus causing COVID-19, has spread globally since March 2020. One of the treatments for people hospitalised with COVID-19 are neutralising monoclonal antibodies, or nMAbs. These are ready-made antibodies that help kill the virus that causes COVID-19, and help people recover more quickly. However, there is evidence that the benefit of treatment of COVID-19 with neutralizing monoclonal antibodies in hospitalised patients, depends on whether the person has already made their own antibodies to fight the virus or not. Those who haven’t already made their own antibodies are more likely to benefit from treatment with nMAbs. There are already a number of rapid tests to check if someone admitted to hospital has already made their own antibodies, some of these will already be in use as part of clinical care. In EPOC we plan to use two different rapid antibody tests and see how these point-of-care (POC) fingerstick test results compare to the antibody levels detected in a blood sample taken at the same time, but stored and frozen and analysed later. Participants in EPOC are being or already admitted to hospital with confirmed COVID-19, and with symptoms of COVID-19 for 12 days or less. Some participants joining EPOC will also be joining a research trial called TICO, which is testing new treatments for people hospitalised with COVID-19, but people being admitted with COVID-19 can join EPOC without being in the TICO trial. While the overall objective of EPOC is to assess the feasibility of using POC antibody tests for patient management, the tests in EPOC won’t be used for clinical management, as this is a research study and not a new device trial.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0126
Date of REC Opinion
23 May 2022
REC opinion
Favourable Opinion