PCR Cycle Threshold Values and COVID-19 Outcomes

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651413
• Other study ID #: 286389
• Status: Completed
• Start date: November 24, 2020
• Est. completion date: October 14, 2021

Study information

• Verified date: December 2020
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 934
• Est. completion date: October 14, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• PCR Value
Data collection and interpretation

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	01/02/2020 to 01/07/2020
Secondary	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.	01/02/2020 to 01/07/2020