PCR Cycle Threshold Values and COVID-19 Outcomes

NCT ID: NCT04651413

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 934 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2021-10-14

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 (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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Covid-19 Ct Value

All patients enrolled onto the ISARIC COVID-19 trial at The University Hospitals of North Midlands NHS Trust between the period 1st February 2020 to 1st July 2020 will be included in this study, provided that a laboratory cycle threshold (Ct) value is available.

PCR Value

Intervention Type: DIAGNOSTIC_TEST

Data collection and interpretation

Interventions

PCR Value

Data collection and interpretation

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals of North Midlands NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Kemp

Role: PRINCIPAL_INVESTIGATOR

UHNM

Locations

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

286389

Identifier Type: -

Identifier Source: org_study_id