Covid19NCT04579458
Assessment of COVID-19 in Tearfilm
An observational study of Covid19 and Ophthalmopathy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
To assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Ophthalmopathy, Eye Diseases
- What is being tested?
- Collection of tears and saliva.
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 22 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent COVID-19 testing at VUMC and tested positive.
Who may be able to join
- Patients who underwent COVID-19 testing at VUMC, tested positive, and had provided a written informed consent to participate in future COVID related studies will be offered participation in this study.
Who cannot join
- Patients under 18.
- Patients who do not speak Spanish or English
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37076
About this study
Official title: Assessment of COVID (Coronavirus Disease)-19 in Tearfilm
To assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months.
Read the detailed description
Patients who underwent COVID-19 testing at VUMC (Vanderbilt University Medical Center) and had provided a written informed consent to be contacted in the future for COVID related studies will be offered participation in this study. The COVID- 19 has low prevalence in ocular fluids (5% of affected patients) but may survive for a long time or replicate in the conjunctiva, even in asymptomatic patients. Patients with viral conjunctivitis are more likely to have COVID-19 RNA (ribonucleic acid) in tears. The use of Schirmer's strips to collect tears for RNA analysis of viruses has been previously validated. VUMC is performing RNA analysis on nasopharyngeal (NP) swabs for COVID-19 at several locations. Several patients (test positive and test negative) have given consent to be contacted for future research purposes and are available in VICTR (Vanderbilt Institute for Clinical and Translational Research) Datamark and Recovery databases. The positive tested patients will receive a Schirmer's strip in the mail at their home to place in both eyes to test eye fluid and receive a tube for saliva while engaging in a zoom session for monitoring of the process.
Methodology: Patients who underwent COVID-19 testing at VUMC and had provided a written informed consent to be contacted in the future for COVID related studies will be offered participation in this study. The first test for eye fluid and saliva will occur at home with remote monitoring. Participants will be mailed a specimen collection kit, engage in a remote session with a study coordinator through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting and collect specimens under supervision of the study coordinator. Patients will receive a Schirmer's strip to place in both eyes without topical proparacaine, and a tube to collect saliva. The strips are then sent to the lab in universal viral transport media. Patients who have positive COVID-19 RNA in tears will get repeat Schirmer's test every 4 weeks for 3 months- independent of the nasopharyngeal test results. After a 3-month period, they will be offered a clinic visit at VEI (Vanderbilt Eye Institute) for full dilated eye exam, fluorescein angiography and aqueous biopsies. Lab testing for COVID-19 RNA and other ocular inflammatory mediators will be performed by Dr. Johnathan Schmitz's lab at VUMC under standard viral precautions. All lab analysis will be performed under a research protocol and not for clinical assessment or reporting.
- Conditions
- Covid19, Ophthalmopathy, Eye Diseases
- Being tested
- Collection of tears and saliva.
- Keywords
- Positive COVID 19, Ophthalmology, Eye Diseases
- Medical subject headings
- COVID-19, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of tears and saliva.Procedure or surgery
Saliva and ocular tears will be collected.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive | COVID-19 positive in nasopharyngeal swabs and tears or saliva. Receives: Procedure: Collection of tears and saliva. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-relation of COVID-19 activity
Patients will receive a Schirmer's strip to place in both eyes without topical proparacaine, and a tube to collect saliva. The co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva will be measured and reported by serial tests over 3 months.
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 posted8 Oct 2020
- Study start28 Dec 2020
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Why it stopped: Not able to enroll the amount required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sapna Gangaputra, Vanderbilt University Medical Center
- Investigators
- Sapna Gangaputra, Principal investigator, Vanderbilt Eye Institiute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579458
- Sponsor's protocol ID
- 201127
- Status last verified
- Feb 2021
- First submitted
- 6 Oct 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Napoli PE, Nioi M, d'Aloja E, Fossarello M. The Ocular Surface and the Coronavirus Disease 2019: Does a Dual 'Ocular Route' Exist? J Clin Med. 2020 Apr 28;9(5):1269. doi: 10.3390/jcm9051269.
PubMed 32353982Xie HT, Jiang SY, Xu KK, Liu X, Xu B, Wang L, Zhang MC. SARS-CoV-2 in the ocular surface of COVID-19 patients. Eye Vis (Lond). 2020 Apr 26;7:23. doi: 10.1186/s40662-020-00189-0. eCollection 2020.
PubMed 32355863Khavandi S, Tabibzadeh E, Naderan M, Shoar S. Corona virus disease-19 (COVID-19) presenting as conjunctivitis: atypically high-risk during a pandemic. Cont Lens Anterior Eye. 2020 Jun;43(3):211-212. doi: 10.1016/j.clae.2020.04.010. Epub 2020 Apr 27. No abstract available.
PubMed 32354654Wu 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 32232433Lee SY, Kim MJ, Kim MK, Wee WR. Comparative analysis of polymerase chain reaction assay for herpes simplex virus 1 detection in tear. Korean J Ophthalmol. 2013 Oct;27(5):316-21. doi: 10.3341/kjo.2013.27.5.316. Epub 2013 Sep 10.
PubMed 24082768WHO. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases - interim guidance. 2020; 2020.
Sullivan PS, Sailey C, Guest JL, Guarner J, Kelley C, Siegler AJ, Valentine-Graves M, Gravens L, Del Rio C, Sanchez TH. Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples. JMIR Public Health Surveill. 2020 Apr 24;6(2):e19054. doi: 10.2196/19054.
PubMed 32310815
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of COVID (Coronavirus Disease)-19 in Tearfilm
- ClinicalTrials.gov ID
- NCT04579458
- Acronym / sponsor ID
- 201127
- Conditions
- Covid19, Ophthalmopathy, Eye Diseases
- Keywords
- Positive COVID 19, Ophthalmology, Eye Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not able to enroll the amount required.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 8 Oct 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 assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months.
Detailed description
Patients who underwent COVID-19 testing at VUMC (Vanderbilt University Medical Center) and had provided a written informed consent to be contacted in the future for COVID related studies will be offered participation in this study. The COVID- 19 has low prevalence in ocular fluids (5% of affected patients) but may survive for a long time or replicate in the conjunctiva, even in asymptomatic patients. Patients with viral conjunctivitis are more likely to have COVID-19 RNA (ribonucleic acid) in tears. The use of Schirmer's strips to collect tears for RNA analysis of viruses has been previously validated. VUMC is performing RNA analysis on nasopharyngeal (NP) swabs for COVID-19 at several locations. Several patients (test positive and test negative) have given consent to be contacted for future research purposes and are available in VICTR (Vanderbilt Institute for Clinical and Translational Research) Datamark and Recovery databases. The positive tested patients will receive a Schirmer's strip in the mail at their home to place in both eyes to test eye fluid and receive a tube for saliva while engaging in a zoom session for monitoring of the process.
Methodology: Patients who underwent COVID-19 testing at VUMC and had provided a written informed consent to be contacted in the future for COVID related studies will be offered participation in this study. The first test for eye fluid and saliva will occur at home with remote monitoring. Participants will be mailed a specimen collection kit, engage in a remote session with a study coordinator through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting and collect specimens under supervision of the study coordinator. Patients will receive a Schirmer's strip to place in both eyes without topical proparacaine, and a tube to collect saliva. The strips are then sent to the lab in universal viral transport media. Patients who have positive COVID-19 RNA in tears will get repeat Schirmer's test every 4 weeks for 3 months- independent of the nasopharyngeal test results. After a 3-month period, they will be offered a clinic visit at VEI (Vanderbilt Eye Institute) for full dilated eye exam, fluorescein angiography and aqueous biopsies. Lab testing for COVID-19 RNA and other ocular inflammatory mediators will be performed by Dr. Johnathan Schmitz's lab at VUMC under standard viral precautions. All lab analysis will be performed under a research protocol and not for clinical assessment or reporting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive | – | Procedure: Collection of tears and saliva.COVID-19 positive in nasopharyngeal swabs and tears or saliva. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent COVID-19 testing at VUMC and tested positive.
Key inclusion criteria (1 listed)
- Patients who underwent COVID-19 testing at VUMC, tested positive, and had provided a written informed consent to participate in future COVID related studies will be offered participation in this study.
Key exclusion criteria (2 listed)
- Patients under 18.
- Patients who do not speak Spanish or English
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 |
|---|---|---|
| Collection of tears and saliva.Saliva and ocular tears will be collected. | Procedure or surgery | COVID-19 Positive |
Primary outcome
Co-relation of COVID-19 activity
Time frame: 3 months
Patients will receive a Schirmer's strip to place in both eyes without topical proparacaine, and a tube to collect saliva. The co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva will be measured and reported by serial tests over 3 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 32353982Napoli PE, Nioi M, d'Aloja E, Fossarello M. The Ocular Surface and the Coronavirus Disease 2019: Does a Dual 'Ocular Route' Exist? J Clin Med. 2020 Apr 28;9(5):1269. doi: 10.3390/jcm9051269.
- Background: PubMed 32355863Xie HT, Jiang SY, Xu KK, Liu X, Xu B, Wang L, Zhang MC. SARS-CoV-2 in the ocular surface of COVID-19 patients. Eye Vis (Lond). 2020 Apr 26;7:23. doi: 10.1186/s40662-020-00189-0. eCollection 2020.
- Background: PubMed 32354654Khavandi S, Tabibzadeh E, Naderan M, Shoar S. Corona virus disease-19 (COVID-19) presenting as conjunctivitis: atypically high-risk during a pandemic. Cont Lens Anterior Eye. 2020 Jun;43(3):211-212. doi: 10.1016/j.clae.2020.04.010. Epub 2020 Apr 27. No abstract available.
- 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.
- Background: PubMed 24082768Lee SY, Kim MJ, Kim MK, Wee WR. Comparative analysis of polymerase chain reaction assay for herpes simplex virus 1 detection in tear. Korean J Ophthalmol. 2013 Oct;27(5):316-21. doi: 10.3341/kjo.2013.27.5.316. Epub 2013 Sep 10.
- BackgroundWHO. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases - interim guidance. 2020; 2020.
- Background: PubMed 32310815Sullivan PS, Sailey C, Guest JL, Guarner J, Kelley C, Siegler AJ, Valentine-Graves M, Gravens L, Del Rio C, Sanchez TH. Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples. JMIR Public Health Surveill. 2020 Apr 24;6(2):e19054. doi: 10.2196/19054.
- 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.
Sapna Gangaputra principal investigator
Vanderbilt Eye Institiute
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 and Ophthalmopathy, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 5 Feb 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Co-relation of COVID-19 activity (time frame: 3 months). 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 NCT04579458, which also lists 7 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 5 Feb 2021.