Covid19NCT04651413
PCR Cycle Threshold Values and COVID-19 Outcomes
An observational study of Covid19, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- PCR Value
- How many people
- 934 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2020to 14 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
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
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.
Read the 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
- Being tested
- PCR Value
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR ValueDiagnostic test
Data collection and interpretation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PCR Value |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 01/02/2020 to 01/07/2020
Secondary outcomes (1)
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.
Measured: 01/02/2020 to 01/07/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start24 Nov 2020
- Primary completion31 Mar 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Kemp, Principal investigator, UHNM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651413
- Sponsor's protocol ID
- 286389
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04651413
- Acronym / sponsor ID
- 286389
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Ct Value | – | Diagnostic Test: PCR ValueAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR ValueData collection and interpretation | Diagnostic test | Covid-19 Ct Value |
Primary outcome
Determine if there is an inverse correlation with risk of poor outcome including admission to intensive care; mechanical ventilation and 28-day mortality.
Time frame: 01/02/2020 to 01/07/2020
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
1 secondary outcome
Differences in cycle threshold (Ct) levels amongst patients with community acquired SARS-CoV-2
Time frame: 01/02/2020 to 01/07/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kemp principal investigator
UHNM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is an inverse correlation with risk of poor outcome including admission to intensive care; mechanical ventilation and 28-day mortality. (time frame: 01/02/2020 to 01/07/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.