COVIDNCT04346160
A Study to Assess the Virus RNA, and miRNA Levels Related to Viral Infection, and Inflammatory Response in Tears of Patients Affected by COVID-19 Disease
An observational study of COVID and Conjunctivitis, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
The aim of this study is to assess the virus RNA, and miRNA levels related to viral infection, and inflammatory response in tears of hospitalized patients with a diagnosis of COVID-19 with and without conjunctivitis and to correlate them with clinical condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID, Conjunctivitis
- What is being tested?
- Schirmer Test I
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2020to 30 Apr 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: a total of 25 patients with a diagnosis of COVID-19 with bilateral conjunctivitis (Group 1) and without conjunctivitis (Group 2) will be enrolled at the Anesthesia and Intensive Care department, the Infectious diseases department and the Emergency Medicine department, at the "SS. Annunziata Hospital" of Chieti-University G. D'Annunzio, Chieti-Pescara, Italy, in April 2020. A group of healthy patients will be enrolled and were considered as controls
Who may be able to join
- A confirmed diagnosis of COVID-19 disease
- Age ≥ of 18 years.
- absence of conjuntivitis detected by portable slit lamp
- A confirmed diagnosis of COVID-19 disease
- Age ≥ of 18 years.
- Presence of bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)
Who cannot join
- Pregnant women
- Any form Ocular surface diseases preceding Covid-19 diagnosis, Glaucoma, history of anterior segment inflammation, previous penetrating ocular trauma
- Ocular surgeries within previous 6 months
- Topical therapies
- History of ocular allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis
The aim of this study is to assess the virus RNA, and miRNA levels related to viral infection, and inflammatory response in tears of hospitalized patients with a diagnosis of COVID-19 with and without conjunctivitis and to correlate them with clinical condition.
Tears will be collected by using Schirmer Test I, a non invasive painless test which can be performed at the patient's bed. Tears will be collected on the graduated paper strips pulling the lower lid gently downward for 5 minutes. Following, the strip will be placed in a 2.0 mL Eppendorf tube and stored at -80◦C (or - 20°C)
Read the detailed description
The SARS-CoV-2 is a virus highly infectious whose main target of infection is the respiratory tract. Virus has been reported to target other mucus tissues, such as the conjunctiva of the eye and causes conjunctivitis. A recent study has detected the presence of SARS-CoV-2 in the tears of patients affected by COVID-19 with conjunctivitis, using real-time reverse transcription polymerase chain reaction (RT-PCR). This suggests that droplets and body fluids of infected people can contaminate the human conjunctival mucosa and it can be a view of transmission that it must not be ignored.
A role of miRNAs has been found in ocular infections such as fungal, bacterial, viral infections. It would be interesting to correlate tear fluid miRNA levels to patients clinical findings
- Conditions
- COVID, Conjunctivitis
- Being tested
- Schirmer Test I
- Keywords
- COVID, conjunctivitis, SARS-CoV2, miRNA, tear fluid
- Medical subject headings
- Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schirmer Test IDiagnostic test
Collection of tear fluid
| Study group | Role | What they receive |
|---|---|---|
| Patients with bilateral conjunctivitis | Hospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) Receives: Diagnostic Test: Schirmer Test I | |
| Patients without conjunctivitis | Hospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) Receives: Diagnostic Test: Schirmer Test I | |
| Healthy control group | group of healthy patients considered as controls Receives: Diagnostic Test: Schirmer Test I |
What is being measured
The primary outcome is the main question the study is designed to answer.
virus molecular analysis
- to asses virus RNA and miRNA levels in tears
Measured: 2 weeks
host molecular analysis
- to asses inflammatory response molecules
Measured: 2 weeks
Secondary outcomes (1)
Epidemiologic data
To analyze the prevalence of conjunctivitis in patients with a diagnosis of COVID-19 and the assessment of the predictive value of conjunctivitis in the development of the COVID-19 disease (or in developing respiratory distress forms-ARDS).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start14 Apr 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Mastropasqua, G. d'Annunzio University
- Investigators
- Leonardo Mastropasqua, Professor, Principal investigator, Ophtalmology Clinic, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346160
- Sponsor's protocol ID
- UChieti03
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Fluid miRNA Analysis in Sars-Cov2 Conjunctivitis
- ClinicalTrials.gov ID
- NCT04346160
- Acronym / sponsor ID
- UChieti03
- Conditions
- COVID, Conjunctivitis
- Keywords
- COVID, conjunctivitis, SARS-CoV2, miRNA, tear fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 14 Apr 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 15 Apr 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 aim of this study is to assess the virus RNA, and miRNA levels related to viral infection, and inflammatory response in tears of hospitalized patients with a diagnosis of COVID-19 with and without conjunctivitis and to correlate them with clinical condition.
Tears will be collected by using Schirmer Test I, a non invasive painless test which can be performed at the patient's bed. Tears will be collected on the graduated paper strips pulling the lower lid gently downward for 5 minutes. Following, the strip will be placed in a 2.0 mL Eppendorf tube and stored at -80◦C (or - 20°C)
Detailed description
The SARS-CoV-2 is a virus highly infectious whose main target of infection is the respiratory tract. Virus has been reported to target other mucus tissues, such as the conjunctiva of the eye and causes conjunctivitis. A recent study has detected the presence of SARS-CoV-2 in the tears of patients affected by COVID-19 with conjunctivitis, using real-time reverse transcription polymerase chain reaction (RT-PCR). This suggests that droplets and body fluids of infected people can contaminate the human conjunctival mucosa and it can be a view of transmission that it must not be ignored.
A role of miRNAs has been found in ocular infections such as fungal, bacterial, viral infections. It would be interesting to correlate tear fluid miRNA levels to patients clinical findings
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with bilateral conjunctivitis | – | Diagnostic Test: Schirmer Test IHospitalized patient affected by COVID-19 disease with bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) |
| Patients without conjunctivitis | – | Diagnostic Test: Schirmer Test IHospitalized patient affected by COVID-19 disease without any signs of conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion) |
| Healthy control group | – | Diagnostic Test: Schirmer Test Igroup of healthy patients considered as controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a total of 25 patients with a diagnosis of COVID-19 with bilateral conjunctivitis (Group 1) and without conjunctivitis (Group 2) will be enrolled at the Anesthesia and Intensive Care department, the Infectious diseases department and the Emergency Medicine department, at the "SS. Annunziata Hospital" of Chieti-University G. D'Annunzio, Chieti-Pescara, Italy, in April 2020. A group of healthy patients will be enrolled and were considered as controls
Key inclusion criteria (6 listed)
- A confirmed diagnosis of COVID-19 disease
- Age ≥ of 18 years.
- absence of conjuntivitis detected by portable slit lamp
- A confirmed diagnosis of COVID-19 disease
- Age ≥ of 18 years.
Key exclusion criteria (5 listed)
- Pregnant women
- Any form Ocular surface diseases preceding Covid-19 diagnosis, Glaucoma, history of anterior segment inflammation, previous penetrating ocular trauma
- Ocular surgeries within previous 6 months
- Topical therapies
- History of ocular allergy
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 |
|---|---|---|
| Schirmer Test ICollection of tear fluid | Diagnostic test | Healthy control group, Patients with bilateral conjunctivitis, Patients without conjunctivitis |
Primary outcome
virus molecular analysis
Time frame: 2 weeks
- to asses virus RNA and miRNA levels in tears
host molecular analysis
Time frame: 2 weeks
- to asses inflammatory response molecules
1 secondary outcome
Epidemiologic data
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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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.
Leonardo Mastropasqua, Professor principal investigator
Ophtalmology Clinic, G. d'Annunzio University
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 COVID and Conjunctivitis, run by G. d'Annunzio University at 1 site in Italy.
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 6 inclusion and 5 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 20 Apr 2020. 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 Italy. 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 Manuela Lanzini, Doctor (+393703005156, m.lanzini@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virus molecular analysis (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 20 Apr 2020.