Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651413
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2020-12-02
Brief Title:
PCR Cycle Threshold Values and COVID-19 Outcomes
Sponsor:
University Hospitals of North Midlands NHS Trust
Organization:
University Hospitals of North Midlands NHS Trust
Study Overview
Official Title:
Can Quantitative Real-time Polymerase Chain Reaction PCR Cycle Threshold Ct Values be Used to Predict Poor Outcomes for Patients Infected With SARS-CoV-2 A Local Exploratory Sub-study at The University Hospitals of North Midlands NHS Trust in Collaboration With the International Severe Acute Respiratory and Emerging Infection Consortium ISARIC COVID-19 Trial
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective observational study The study will use high quality reliable data that has already been collected for the ISARIC 4C COVID-19 study in order to analyse the relation between predictor variables laboratory polymerase chain reaction PCR cycle threshold Ct values and outcomes for COVID-19 disease within a hospitalised population
Detailed Description:
Currently in the United Kingdom the recommended method for diagnostic testing and screening for COVID-19 is quantitative real-time reverse transcription polymerase chain reaction PCR analysis of viral RNA extracted from upper respiratory tract samples A positive result indicates that SARS-CoV-2 RNA has been detected with a cycle threshold Ct value of less than 38 cycles of amplification nb this is a locally agreed value which is based on analysis of proficiency testing performance and other local testing data Cycle threshold Ct values inversely correlate to the amount of target nucleic acid in the sample Thus a lower cycle threshold Ct value indicates a greater amount of target nucleic acid in a sample ie a higher viral load
A recent scoping literature review has revealed only a handful of published studies to date that explore an association between cycle threshold Ct values and disease severity or clinical outcome in patients infected with the SARS-CoV-2 virus The majority of these studies have been conducted in China with small patient sample sizes Thus a larger-scale study which explores the relationship between viral load and disease severity is required indeed the World Health Organization WHO has recently highlighted this as an area which needs further research
A recent scoping literature review has revealed only a handful of published studies to date that explore an association between cycle threshold Ct values and disease severity or clinical outcome in patients infected with the SARS-CoV-2 virus The majority of these studies have been conducted in China with small patient sample sizes Thus a larger-scale study which explores the relationship between viral load and disease severity is required indeed the World Health Organization WHO has recently highlighted this as an area which needs further research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None