PCR Cycle Threshold Values and COVID-19 Outcomes

University Hospitals of North Midlands NHS Trust934 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

934

Conditions

Covid19

Interventions

PCR ValueDIAGNOSTIC_TEST

Data collection and interpretation

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult (aged 18 years and over) patients presenting to UHNM with confirmed SARS-CoV-2 infection AND who are enrolled onto the ISARIC COVID-19 study. 2. Patients who have undergone an initial diagnostic or screening test for SARS-CoV-2 (from an upper respiratory tract sample) AND a cycle threshold (Ct) value is available on the UHNM laboratory database. Exclusion Criteria: 1. Paediatric patients (under 18 years). 2. Patients without a PCR Ct result on the UHNM laboratory database 3. Patients without confirmed SARS-CoV-2 infection 4. Patients who were not enrolled in to the ISARIC COVID-19 study

Locations (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Outcomes

Primary Outcomes

Determine if there is an inverse correlation with risk of poor outcome including admission to intensive care; mechanical ventilation and 28-day mortality.

Determine if cycle threshold (Ct) levels are an independent predictor for: I. Hypoxia resulting in oxygen dependency or oxygen saturations \< 92%, at admission and at any other point during the episode of care; II. admission to intensive care; III. mechanical ventilation and

Time frame: 01/02/2020 to 01/07/2020

Secondary Outcomes

Differences in cycle threshold (Ct) levels amongst patients with community acquired SARS-CoV-2

Determine if sociodemographic factors are significantly associated with lower cycle threshold (Ct) levels.

Time frame: 01/02/2020 to 01/07/2020

Data from ClinicalTrials.gov

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