Covid19NCT04907981
Eye Detection to Identify Novel Coronavirus Infection
An observational study of Covid19, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The eye characteristics of patients with COVID-19 and those without the disease were analyzed, and whether they had the disease or not was judged according to the eye characteristics. Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Novel coronavirus infection
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2021to 26 Apr 2021
- How long will I take part?
- 1 Day
- 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 Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hospital
Who may be able to join
- All participants were provided with written informed consent at the time of recruitment；
- Age ≥ 18 and ≤ 75 (informed consent signed by guardian under 18)
- Meet the diagnostic criteria of novel coronavirus (2019-COVID-19) infection
Who cannot join
- Does not meet any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Screening Based on Feature Recognition and Detection of Eye Surface Images of COVID-2019 Patients and Statistical Analysis of High-dimensional Data
The eye characteristics of patients with COVID-19 and those without the disease were analyzed, and whether they had the disease or not was judged according to the eye characteristics.
Read the detailed description
To test the accuracy of a non-invasive eye monitoring that can be widely used for screening in judging patients with novel coronavirus infection.
- Conditions
- Covid19
- Being tested
- Novel coronavirus infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel coronavirus infectionDiagnostic test
Using eye examination to judge whether novel coronavirus is infected or not.
| Study group | Role | What they receive |
|---|---|---|
| Novel coronavirus infection | All patients were diagnosed according to the diagnostic criteria of the National Health Commission of China and confirmed by RT-PCR detection of viral nucleic acids. Receives: Diagnostic Test: Novel coronavirus infection | |
| Not infected by novel coronavirus | Healthy controls and patients with liver disease | |
| Recovered patients with nucleic acid negative after infection with novel coronavirus | Novel coronavirus nucleic acid changed from positive to negative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection and analysis of eye characteristics of patients encoding criteria, annotation of ocular feature
Ocular pathological features
Measured: 1DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start22 Jan 2021
- Primary completion26 Apr 2021
- Study completion26 Apr 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.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 232 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Hubei Hospital of Traditional Chinese Medicine, Fifth Hospital of Shijiazhuang City
- Responsible party
- Sponsor
- Investigators
- Lei zhao, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907981
- Sponsor's protocol ID
- COVID-19
- Status last verified
- Jun 2021
- First submitted
- 23 May 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Screening Based on Feature Recognition and Detection of Eye Surface Images of COVID-2019 Patients and Statistical Analysis of High-dimensional Data
- ClinicalTrials.gov ID
- NCT04907981
- Acronym / sponsor ID
- COVID-19
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Fudan University, Hubei Hospital of Traditional Chinese Medicine, Fifth Hospital of Shijiazhuang City
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 1 Jun 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.
The eye characteristics of patients with COVID-19 and those without the disease were analyzed, and whether they had the disease or not was judged according to the eye characteristics.
Detailed description
To test the accuracy of a non-invasive eye monitoring that can be widely used for screening in judging patients with novel coronavirus infection.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novel coronavirus infection | – | Diagnostic Test: Novel coronavirus infectionAll patients were diagnosed according to the diagnostic criteria of the National Health Commission of China and confirmed by RT-PCR detection of viral nucleic acids. |
| Not infected by novel coronavirus | – | –Healthy controls and patients with liver disease |
| Recovered patients with nucleic acid negative after infection with novel coronavirus | – | –Novel coronavirus nucleic acid changed from positive to negative. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (3 listed)
- All participants were provided with written informed consent at the time of recruitment；
- Age ≥ 18 and ≤ 75 (informed consent signed by guardian under 18)
- Meet the diagnostic criteria of novel coronavirus (2019-COVID-19) infection
Key exclusion criteria (1 listed)
- Does not meet any of the inclusion criteria
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 |
|---|---|---|
| Novel coronavirus infectionUsing eye examination to judge whether novel coronavirus is infected or not. | Diagnostic test | Novel coronavirus infection |
Primary outcome
Collection and analysis of eye characteristics of patients encoding criteria, annotation of ocular feature
Time frame: 1DAY
Ocular pathological features
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 14 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Lei zhao principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 14 Jun 2021. 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 China. 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?
Collection and analysis of eye characteristics of patients encoding criteria, annotation of ocular feature (time frame: 1DAY). 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 14 Jun 2021.