Sars-CoV2NCT04402853
SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients
An observational study of Sars-CoV2 and Tear, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Tears swab
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 20 May 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: Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia
Who may be able to join
- Hospitalized COVID 19 patients
Who cannot join
- Patients with respiratory support that interferes with tears sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients
Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.
Read the detailed description
Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment.
At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated.
The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions
- Being tested
- Tears swab
- Keywords
- COVID 19, EYE, Tears
- Medical subject headings
- Lacerations, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tears swabDiagnostic test
rtPCR on tears swabs samples
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 Patients | hospitalized patients with COVID 19 Receives: Diagnostic Test: Tears swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus presence in COVID 19 patients tears
prevalence of SARS CoV 2 virus on tears
Measured: 1 day
Secondary outcomes (1)
Concordance to Naso-Pharingeal Swab
Evaluation of concordance with Naso-Pharingeal testing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Feb 2020
- Primary completion1 Mar 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Donati, Università degli Studi dell'Insubria
- Investigators
- Simone Donati, Professor, Principal investigator, University of Insubria, Varese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402853
- Sponsor's protocol ID
- 72/2020
- Status last verified
- Dec 2020
- First submitted
- 22 May 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study will be published
Publications
Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.
PubMed 32232433Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.
PubMed 32336042
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients
- ClinicalTrials.gov ID
- NCT04402853
- Acronym / sponsor ID
- 72/2020
- Keywords
- COVID 19, EYE, Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 27 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.
Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19 patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant systemic clinical conditions.
Detailed description
Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory syndrome started in China and rapidly spread all over the world and in particular in northern Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with Chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment.
At now, more than eighty thousand citizens from Lombardia Region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated.
The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and to correlate virus presence to concomitant systemic clinical conditions
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID 19 Patients | – | Diagnostic Test: Tears swabhospitalized patients with COVID 19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia
Key inclusion criteria (1 listed)
- Hospitalized COVID 19 patients
Key exclusion criteria (1 listed)
- Patients with respiratory support that interferes with tears sampling
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 |
|---|---|---|
| Tears swabrtPCR on tears swabs samples | Diagnostic test | COVID 19 Patients |
Primary outcome
Virus presence in COVID 19 patients tears
Time frame: 1 day
prevalence of SARS CoV 2 virus on tears
1 secondary outcome
Concordance to Naso-Pharingeal Swab
Time frame: 1 day
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 3 Dec 2020.
- Background: PubMed 32232433Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.
- Results publication: PubMed 32336042Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.
- tears and infectionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The study will be published
Related trials for Sars-CoV2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Simone Donati, Professor principal investigator
University of Insubria, Varese
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 Sars-CoV2 and Tear, run by Università degli Studi dell'Insubria 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 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: finished, as of the sponsor's last update on 3 Dec 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?
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?
Virus presence in COVID 19 patients tears (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402853, which also lists 2 linked publications.
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 3 Dec 2020.