PCR Cycle Threshold Values and COVID-19 Outcomes

NCT04651413 | Completed

• 1 other identifier: 286389
• Study Type: observational
• Target: 934
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  01/02/2020 to 01/07/2020

Study Arms (1)

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.

Diagnostic Test: PCR Value

Interventions

PCR Value DIAGNOSTIC_TEST

Data collection and interpretation

Covid-19 Ct Value

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults (aged 18 years and over) patients presenting to UHNM with confirmed SARS-CoV-2 infection and who are enrolled onto the ISARIC 4C COVID-19 study. These patients must also 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Paediatric patients (under 18 years).
• Patients without a PCR Ct result on the UHNM laboratory database
• Patients without confirmed SARS-CoV-2 infection
• Patients who were not enrolled in to the ISARIC COVID-19 study

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Timothy Kemp

  UHNM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 3, 2020
• Study Start: November 24, 2020
• Primary Completion: March 31, 2021
• Study Completion: October 14, 2021
• Last Updated: May 18, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)