Covid19NCT04640428
COVID-19 Stroke Apical Lung Examination Study
An observational study of Covid19 and Stroke, Acute, run by King's College Hospital NHS Trust at 12 sites in United Kingdom.
Trial summary
Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Stroke, Acute, Stroke, Ischemic
- How many people
- 2,000 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 10 Jul 2020to 31 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients presenting to participating centres with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.
Who may be able to join
- All adult patients presenting with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.
Who cannot join
- Poor image quality. No radiologist report available. Computed tomography angiography performed in a non-acute setting.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Recruiting
Royal United Hospitals Bath NHS Foundation Trust
Bath
Tim Burkett
- Recruiting
North Bristol NHS Trust
Bristol
Teo
Teo Lopez-Bernal
- Recruiting
University Hospitals Bristol NHS Foundation Trust
Bristol
Teo Lopez-Bernal
- Recruiting
Frimley Health NHS Foundation Trust
Camberley
Robert Barker
- Recruiting
Cardiff and Vale University Health Board
Cardiff
Saptarshi Mukherjee
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Ajit Kishore
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Jim Zhong
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Virjen Patel
- Recruiting
Imperial College Healthcare NHS Foundation Trust
London
Jack Garnham
- Recruiting
King's College Hospital NHS FT (KCH)
London
Thomas Booth, 02078489568, thomas.booth@kcl.ac.uk
- Recruiting
King's College Hospital NHS FT (PRUH)
London
Priyan Tantrige
- Recruiting
University College London NHS Foundation Trust
London
Indran Davagnanam
About this study
Official title: COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study
Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker.
Read the detailed description
Diagnosis of coronavirus disease 2019 (COVID-19) relies on clinical features and reverse-transcriptase polymerase chain reaction (RT-PCR) testing. The latter is constrained by limited sensitivity and a timescale of hours to yield results, with no point-of-care test widely available. A dedicated computed tomography study of the chest is likely to be more sensitive than RT-PCR for COVID-19. Carotid computed tomography angiography (CTA) is a routine acute stroke investigation and includes the lung apices. We aim to assess the lung apices on CTA for ground glass opacification and compare this with COVID-19 RT-PCR test results and clinical outcome measures.
- Conditions
- Covid19, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic
- Keywords
- COVID, stroke, CT, CTA
- Medical subject headings
- COVID-19, Stroke, Ischemic Stroke, Hemorrhagic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test
Defined by sensitivity, specificity, positive and negative predictive values
Measured: 1 month
Secondary outcomes (1)
Prognostic value of the computed tomography biomarker
Defined by its relationship with 30 day mortality and modified rankin scale following treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start10 Jul 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640428
- Sponsor's protocol ID
- COVID SALES 2
- Status last verified
- May 2021
- First submitted
- 20 Nov 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study
- ClinicalTrials.gov ID
- NCT04640428
- Acronym / sponsor ID
- COVID SALES 2
- Conditions
- Covid19, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic
- Keywords
- COVID, stroke, CT, CTA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 23 Nov 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.
Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker.
Detailed description
Diagnosis of coronavirus disease 2019 (COVID-19) relies on clinical features and reverse-transcriptase polymerase chain reaction (RT-PCR) testing. The latter is constrained by limited sensitivity and a timescale of hours to yield results, with no point-of-care test widely available. A dedicated computed tomography study of the chest is likely to be more sensitive than RT-PCR for COVID-19. Carotid computed tomography angiography (CTA) is a routine acute stroke investigation and includes the lung apices. We aim to assess the lung apices on CTA for ground glass opacification and compare this with COVID-19 RT-PCR test results and clinical outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients presenting to participating centres with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.
Key inclusion criteria (1 listed)
- All adult patients presenting with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.
Key exclusion criteria (1 listed)
- Poor image quality. No radiologist report available. Computed tomography angiography performed in a non-acute setting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test
Time frame: 1 month
Defined by sensitivity, specificity, positive and negative predictive values
1 secondary outcome
Prognostic value of the computed tomography biomarker
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Active, not recruitingObservational study
A Study to Learn About COVID-19 Antivirals in People With SARS-CoV-2 Infection From 2023-2026
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Stroke, Acute, run by King's College Hospital NHS Trust at 12 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan Chan, FRCR (+44(0)7508192126, covidsalesresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test (time frame: 1 month). 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 27 May 2021.