Covid19COVID VOICENCT04855539
Coronavirus: Ventilator Outcomes Using Artificial Intelligence Chest Radiographs & Other Evidence-based Co-variates
An observational study of Covid19 and Pneumonia, run by King's College Hospital NHS Trust at 3 sites in United Kingdom.
Trial summary
We will determine ventilator outcomes to Coronavirus Infectious Disease 2019 (COVID-19) using artificial Intelligence with inputs of chest radiographs and other evidence-based co-variates. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 300 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Mar 2020to 1 Dec 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 adults with COVID-19 at secondary and tertiary centres
Who may be able to join
- Admitted to intensive care unit (ITU) or equivalent COVID-19 polymerase chain reaction (PCR) positive
Who cannot join
- No imaging prior to ITU admission
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Guy's and St Thomas' Hospital
London
Vicky Goh, FRCR
- Recruiting
King's College Hospital
London
Thomas Booth, PhD
- Recruiting
Princess Royal University Hospital
Orpington, Kent
James Teo, PhD
About this study
Official title: Coronavirus Infectious Disease 2019: Ventilator Outcomes Using Artificial Intelligence, Chest Radiographs and Other Evidence-based Co-variates (COVID VOICE)
We will determine ventilator outcomes to Coronavirus Infectious Disease 2019 (COVID-19) using artificial Intelligence with inputs of chest radiographs and other evidence-based co-variates.
Read the detailed description
The chest radiograph (chest x-ray) has emerged as the United Kingdom's National Health Service (NHS) frontline diagnostic imaging test for COVID-19, in conjunction with clinical history and key blood markers: C-reactive protein (CRP) and lymphopenia. Typically, every suspected COVID-19 patient presenting to the emergency department is undergoing blood tests and a chest radiograph. Therefore, it has become critical for radiologists to review and "hot" report the chest x-ray urgently.
Primary Objective: Use chest radiographs and clinical data to determine whether patient can survive with a ventilator
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| wave 1 | Not described | |
| wave 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of a convolutional neural network to predict survival outcome
Defined by sensitivity, specificity, positive and negative predictive values
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 posted22 Apr 2021
- Study start1 Mar 2020
- Primary completion1 May 2021
- Study completion1 Dec 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.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855539
- Sponsor's protocol ID
- IRAS 232823
- Acronym
- COVID VOICE
- Status last verified
- Sep 2021
- First submitted
- 19 Apr 2021
- Last updated
- 16 Sep 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronavirus Infectious Disease 2019: Ventilator Outcomes Using Artificial Intelligence, Chest Radiographs and Other Evidence-based Co-variates (COVID VOICE)
- ClinicalTrials.gov ID
- NCT04855539
- Acronym / sponsor ID
- COVID VOICE / IRAS 232823
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 22 Apr 2021 (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.
We will determine ventilator outcomes to Coronavirus Infectious Disease 2019 (COVID-19) using artificial Intelligence with inputs of chest radiographs and other evidence-based co-variates.
Detailed description
The chest radiograph (chest x-ray) has emerged as the United Kingdom's National Health Service (NHS) frontline diagnostic imaging test for COVID-19, in conjunction with clinical history and key blood markers: C-reactive protein (CRP) and lymphopenia. Typically, every suspected COVID-19 patient presenting to the emergency department is undergoing blood tests and a chest radiograph. Therefore, it has become critical for radiologists to review and "hot" report the chest x-ray urgently.
Primary Objective: Use chest radiographs and clinical data to determine whether patient can survive with a ventilator
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wave 1 | – | – |
| wave 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with COVID-19 at secondary and tertiary centres
Key inclusion criteria (1 listed)
- Admitted to intensive care unit (ITU) or equivalent COVID-19 polymerase chain reaction (PCR) positive
Key exclusion criteria (1 listed)
- No imaging prior to ITU admission
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
Sensitivity and specificity of a convolutional neural network to predict survival outcome
Time frame: 1 month
Defined by sensitivity, specificity, positive and negative predictive values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
3 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 Pneumonia, run by King's College Hospital NHS Trust at 3 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Thomas C Booth, PhD (+44203299482, thomas.booth@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of a convolutional neural network to predict survival outcome (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 16 Sep 2021.