COVIDNCT04526769
Detecting SARS-CoV-2 in Tears
An observational study of COVID and COVID-19, run by University of Minnesota at 1 site in United States.
Trial summary
Purpose: To determine the presence of SARS-CoV-2 in tears To determine SARS-CoV-2 receptors in tear production system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, COVID-19, Corona Virus Infection
- What is being tested?
- Tear Collection
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Dec 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: Consecutive patients meeting inclusion criteria who are willing to participate will be included until the total number of 30 participants is reached.
Who may be able to join
- Patients presenting at study sites with confirmed or suspected COVID-19
Who cannot join
- Pregnancy or nursing
- non-English speakers
- Those unable to read
- Those in other vulnerable study populations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Detecting SARS-CoV-2 Virus in Tears From Patients With COVID-19
Purpose:
- To determine the presence of SARS-CoV-2 in tears
- To determine SARS-CoV-2 receptors in tear production system
Read the detailed description
This is a prospective case series. NP swab and tear samples will be collected simultaneously from the confirmed or suspected COVID-19 patients. The samples will be transferred to the lab for SARS-CoV-2 testing. The presence of absence of SARS-CoV-2 will be compared in tears versus NP swabs.
The second part of the study is a histopathology examination series. Normal lacrimal gland and ocular surface tissue samples already stored at the UMN ocular pathology lab and Lion's Gift of Sight Eye Bank will be used for IHC staining for ACE2 and similar targets.
- Conditions
- COVID, COVID-19, Corona Virus Infection, SARS-CoV-2
- Being tested
- Tear Collection
- Keywords
- COVID-19, SARS-CoV-2, Tear, Nasopharyngeal Swab
- Medical subject headings
- COVID-19, Coronavirus Infections, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear CollectionDiagnostic test
A microcapillary tube will be placed at the corner of the eyelid so tears can be absorbed to the tube without causing any trauma. The tube will be placed in a transfer tube. Standard virus sampling swabs will be used to collect samples from the same patient's nasopharynx. RT-PCR will be run to determine virus yield in each sample.
For the second part of the study, IHC staining will be done on the existing ocular tissue pathology slides to detect the expression of ACE2 and other cell surface and intracellular receptors. The investigators will use existing UMN ocular pathology lab and Lion's Eye Bank tissue samples. These are banked tissue samples that were collected and examined previously and then the remaining tissue samples were stored.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Patients | All patients aged 18 years and above who present to Fairview/UMN ERs or ICUs with confirmed or suspect COVID-19 based on the attending physician's judgment will be included. Receives: Diagnostic Test: Tear Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Virus Detection in Tears
Outcome is reported as the percent of tear samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.
Measured: At day 1 of study participation
COVID-19 Virus Detection in Nasopharyngeal Swabs
Outcome is reported as the percent of nasopharyngeal swab samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.
Measured: At day 1 of study participation
Secondary outcomes (2)
Expression of ACE2 in Lacrimal Gland Samples
Pathology slides of lacrimal gland samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of lacrimal gland samples scored in each category (no expression, mild expression, or heavy expression).
Measured: At day 1 of study participation
Expression of ACE2 in Ocular Surface Samples
Pathology slides of ocular surface samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of ocular surface samples scored in each category (no expression, mild expression, or heavy expression).
Measured: At day 1 of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Sep 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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.
- More trials run by University of MinnesotaThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hossein Nazari, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526769
- Sponsor's protocol ID
- OVNS-2020-29066
- Status last verified
- Oct 2022
- First submitted
- 21 Aug 2020
- Last updated
- 31 Oct 2022
- 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting SARS-CoV-2 Virus in Tears From Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04526769
- Acronym / sponsor ID
- OVNS-2020-29066
- Conditions
- COVID, COVID-19, Corona Virus Infection, SARS-CoV-2
- Keywords
- COVID-19, SARS-CoV-2, Tear, Nasopharyngeal Swab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Aug 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.
Purpose:
- To determine the presence of SARS-CoV-2 in tears
- To determine SARS-CoV-2 receptors in tear production system
Detailed description
This is a prospective case series. NP swab and tear samples will be collected simultaneously from the confirmed or suspected COVID-19 patients. The samples will be transferred to the lab for SARS-CoV-2 testing. The presence of absence of SARS-CoV-2 will be compared in tears versus NP swabs.
The second part of the study is a histopathology examination series. Normal lacrimal gland and ocular surface tissue samples already stored at the UMN ocular pathology lab and Lion's Gift of Sight Eye Bank will be used for IHC staining for ACE2 and similar targets.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Patients | – | Diagnostic Test: Tear CollectionAll patients aged 18 years and above who present to Fairview/UMN ERs or ICUs with confirmed or suspect COVID-19 based on the attending physician's judgment will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients meeting inclusion criteria who are willing to participate will be included until the total number of 30 participants is reached.
Key inclusion criteria (1 listed)
- Patients presenting at study sites with confirmed or suspected COVID-19
Key exclusion criteria (4 listed)
- Pregnancy or nursing
- non-English speakers
- Those unable to read
- Those in other vulnerable study populations
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 |
|---|---|---|
| Tear CollectionA microcapillary tube will be placed at the corner of the eyelid so tears can be absorbed to the tube without causing any trauma. The tube will be placed in a transfer tube. Standard virus sampling swabs will be used to collect samples from the same patient's nasopharynx. RT-PCR will be run to determine virus yield in each sample. For the second part of the study, IHC staining will be done on the existing ocular tissue pathology slides to detect the expression of ACE2 and other cell surface and intracellular receptors. The investigators will use existing UMN ocular pathology lab and Lion's Eye Bank tissue samples. These are banked tissue samples that were collected and examined previously and then the remaining tissue samples were stored. | Diagnostic test | COVID-19 Patients |
Primary outcome
COVID-19 Virus Detection in Tears
Time frame: At day 1 of study participation
Outcome is reported as the percent of tear samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.
COVID-19 Virus Detection in Nasopharyngeal Swabs
Time frame: At day 1 of study participation
Outcome is reported as the percent of nasopharyngeal swab samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.
2 secondary outcomes
Expression of ACE2 in Lacrimal Gland Samples
Time frame: At day 1 of study participation
Expression of ACE2 in Ocular Surface Samples
Time frame: At day 1 of study participation
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 31 Oct 2022.
- 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.
Hossein Nazari, MD principal investigator
University of Minnesota
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 COVID-19, run by University of Minnesota 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 4 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 31 Oct 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 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 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?
COVID-19 Virus Detection in Tears (time frame: At day 1 of study participation). 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 31 Oct 2022.