SARS-CoV InfectionP20/09NCT04397666
RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19
A study testing conjunctival RT PCR in people with SARS-CoV Infection and Pinkeye, run by Versailles Hospital at 1 site in France.
Trial summary
the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Pinkeye
- What is being tested?
- conjunctival RT PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2020to 15 Dec 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
- Men and Women positive for SARS-Cov-2 on a RT-PCR test of a sample of respiratory airway
- Persons over 18 years of age
- patients of both sexes
- Member of a social security scheme
- Having signed the consent form
Who cannot join
- Minors not emancipated, persons out of state to express their consent
- Participation in intervention research on Covid-19 involving experimental treatment
- History of chronic disease conjunctiva
- Patient with one of the one of the criteria of following gravity:
- EN > or =30/min,
- Pao2/Fio2 = or < 300,
Show all 10Show fewer
- confusion and/or disorientation,
- hypotension (Tas90mmhg, requiring aggressive filling),
- need for a invasive ventilation,
- septic shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19
the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients
- Conditions
- SARS-CoV Infection, Pinkeye
- Being tested
- conjunctival RT PCR
- Medical subject headings
- Severe Acute Respiratory Syndrome, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjunctival RT PCRDiagnostic test
conjunctival sample in covid-19 patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Diagnostic Test: conjunctival RT PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start15 May 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edouard KOCH, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397666
- Sponsor's protocol ID
- P20/09_COVEYES
- Acronym
- P20/09
- Status last verified
- Aug 2021
- First submitted
- 20 May 2020
- Last updated
- 9 Aug 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19
- ClinicalTrials.gov ID
- NCT04397666
- Acronym / sponsor ID
- P20/09 / P20/09_COVEYES
- Conditions
- SARS-CoV Infection, Pinkeye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 21 May 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.
the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Diagnostic Test: conjunctival RT PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and Women positive for SARS-Cov-2 on a RT-PCR test of a sample of respiratory airway
- Persons over 18 years of age
- patients of both sexes
- Member of a social security scheme
- Having signed the consent form
Key exclusion criteria (10 listed)
- Minors not emancipated, persons out of state to express their consent
- Participation in intervention research on Covid-19 involving experimental treatment
- History of chronic disease conjunctiva
- Patient with one of the one of the criteria of following gravity:
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 RT PCRconjunctival sample in covid-19 patients | Diagnostic test | 1 |
Primary outcome
the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
Time frame: 3 months
to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 RT PCR in people with SARS-CoV Infection and Pinkeye, run by Versailles Hospital 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 5 inclusion and 10 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 9 Aug 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 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?
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?
the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis (time frame: 3 months). 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 Aug 2021.