NCT04651413

PCR Cycle Threshold Values and COVID-19 Outcomes

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
• Phase: —
• Study type: Observational
• Enrollment: 934 (actual)
• Sponsor: University Hospitals of North Midlands NHS Trust · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 (n.b. 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 i.e. 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.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PCR Value	Data collection and interpretation

Timeline

• Start date: 2020-11-24
• Primary completion: 2021-03-31
• Completion: 2021-10-14
• First posted: 2020-12-03
• Last updated: 2022-05-18

Locations

1 site across 1 country: United Kingdom