SARS-CoV-2COVIDEYENCT04654325
Prevalence of SARS-CoV-2 Genome in Tears of Asymptomatic and Moderately Symptomatic COVID-19 Patients
A study testing conjunctival swab in people with SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To evaluate the prevalence of SARS-CoV-2 genome in patients with asymptomatic and moderately symptomatic COVID19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- conjunctival swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2021to 29 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients receiving diagnostic nasopharyngeal PCR for COVID-19 as part of the usual care
- Age ≥ 18.
- Information and signature of consent
- Affiliated with a social security scheme or entitled
Who cannot join
- Refusal to participate in the study
- Eye surgery less than 3 months old
- Unable to give informed consent
- No coverage through the health insurance system
- Patient under judicial protection
- Patient on AME
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the prevalence of SARS-CoV-2 genome in patients with asymptomatic and moderately symptomatic COVID19.
Read the detailed description
Patients attending to the COVID19 screening facility of Paris South University hospital and willing to participate to the study will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. The project will evaluate the prevalence of positive conjunctival swabs in patients with positive nasopharyngeal swab. These results will be corelated to symptoms of disease assessed with a standardized questionnaire.
- Conditions
- SARS-CoV-2
- Being tested
- conjunctival swab
- Keywords
- SARS-CoV-2, COVID19, conjunctiva, tears
- Medical subject headings
- COVID-19, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjunctival swabDiagnostic test
Patients will have conjunctival swab for SARS-CV-2 genome detection
| Study group | Role | What they receive |
|---|---|---|
| Patients attending to the COVID19 screening facility | Other | Patients will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. Study will evaluate the prevalence of positive conjunctival swabs in patients with positive nasopharyngeal swab. These results will be corelated to symptoms of disease assessed with a stan Receives: Diagnostic Test: conjunctival swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of SARS-CoV-2 genome in tears
Prevalence of SARS-CoV-2 genome in tears
Measured: at the end of the study, an average of 1 year
Secondary outcomes (2)
presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation
correlation between systemic symptoms (fever, chills, sweating, muscle aches, headache, runny or stuffy nose, cough, sore throat, asthenia, anosmia, agueusia, unusual shortness of breath, skin rash diarrhea, nausea vomiting) and positive conjunctival swab
Measured: at the end of the study, an average of 1 year
assessement of viral load levels
correlation between nasopharyngeal viral load and conjunctival load (indirectly assessed with cycle thresholds quantification method)
Measured: at the end of the study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start19 Jan 2021
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Why it stopped: less covid testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Rousseau, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654325
- Sponsor's protocol ID
- APHP201268
- Other IDs
- 2020-A02996-33
- Acronym
- COVIDEYE
- Status last verified
- Sep 2022
- First submitted
- 30 Nov 2020
- Last updated
- 9 Sep 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 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of SARS-CoV-2 Genome in Tears of Asymptomatic and Moderately Symptomatic COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04654325
- Acronym / sponsor ID
- COVIDEYE / APHP201268
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID19, conjunctiva, tears
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: less covid testing
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 4 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.
To evaluate the prevalence of SARS-CoV-2 genome in patients with asymptomatic and moderately symptomatic COVID19.
Detailed description
Patients attending to the COVID19 screening facility of Paris South University hospital and willing to participate to the study will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. The project will evaluate the prevalence of positive conjunctival swabs in patients with positive nasopharyngeal swab. These results will be corelated to symptoms of disease assessed with a standardized questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending to the COVID19 screening facility | Other | Diagnostic Test: conjunctival swabPatients will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. Study will evaluate the prevalence of positive conjunctival swabs in patients with positive nasopharyngeal swab. These results will be corelated to symptoms of disease assessed with a stan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving diagnostic nasopharyngeal PCR for COVID-19 as part of the usual care
- Age ≥ 18.
- Information and signature of consent
- Affiliated with a social security scheme or entitled
Key exclusion criteria (6 listed)
- Refusal to participate in the study
- Eye surgery less than 3 months old
- Unable to give informed consent
- No coverage through the health insurance system
- Patient under judicial protection
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 |
|---|---|---|
| conjunctival swabPatients will have conjunctival swab for SARS-CV-2 genome detection | Diagnostic test | Patients attending to the COVID19 screening facility |
Primary outcome
presence of SARS-CoV-2 genome in tears
Time frame: at the end of the study, an average of 1 year
Prevalence of SARS-CoV-2 genome in tears
2 secondary outcomes
presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation
Time frame: at the end of the study, an average of 1 year
assessement of viral load levels
Time frame: at the end of the study, an average of 1 year
Results and safety
The study was stopped early (reason given: less covid testing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
Antoine Rousseau, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conjunctival swab in people with SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Sep 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 France. 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 was stopped early (reason given: less covid testing). Results are not available in the source record.
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?
presence of SARS-CoV-2 genome in tears (time frame: at the end of the study, an average of 1 year). 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 9 Sep 2022.