PCR cycle threshold levels and COVID-19 outcomes [COVID-19]
Research type
Research Study
Full title
Can quantitative (real-time) PCR cycle threshold (Ct) values be used to predict poor outcomes for patients infected with SARS-CoV-2? A retrospective observational sub-study at The University Hospitals of North Midlands NHS Trust (UHNM) in collaboration with the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) 4C COVID-19 study.
IRAS ID
286389
Contact name
Timothy Kemp
Contact email
Sponsor organisation
University Hospitals of North Midlands NHS Trust
Clinicaltrials.gov Identifier
LPR 2859, LPR 2859
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
COVID19 is an evolving global health crisis, and so far there have been >26 million cases, and >860,000 deaths. Most people who become infected recover fully but there are a significant number of people who will become very unwell and will need admission to hospital, and some will require intensive care support, for example being put onto a ventilator. Being able to predict early during a hospital admission which individuals are likely to become very unwell and are at a high risk of dying or needing Intensive Care would be very helpful in getting the right treatment available quickly.
Diagnosing someone with COVID 19 is done by taking a swab from the nose and throat, and analysing it using a laboratory technique called PCR which copies the genetic material present in the COVID19 virus. Each round of copying is "One Cycle". To prove that the virus is present (and therefore get a positive test), the laboratory needs to perform a number of these Cycles. The number of cycles (cycle time, (CT)) can be used to calculate how much virus was present on the sample; test results with a lower CT value means that there was a lot of virus present on the sample.
This project aims to see whether the cycle time value for patients admitted to the University Hospitals of North Midlands (UHNM) can predict which patients are at risk of a poor outcome. There is a large amount of information that has already been collected by the ISARIC study for patients admitted with COVID19 to UHNM; and we will add the CT values to this data set. The data will be analysed by a senior statistician, and we hope that the outcome will show whether CT values are a valuable tool in triaging patients admitted with COVID19. [Study relying on COPI notice]
REC name
London - Chelsea Research Ethics Committee
REC reference
20/HRA/3967
Date of REC Opinion
10 Nov 2020
REC opinion
Favourable Opinion