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Assessment of COVID-19 in Tearfilm

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ClinicalTrials.gov Identifier: NCT04579458
Recruitment Status : Withdrawn (Not able to enroll the amount required.)
First Posted : October 8, 2020
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Sapna Gangaputra, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Covid19 Ophthalmopathy Eye Diseases Procedure: Collection of tears and saliva.

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of COVID (Coronavirus Disease)-19 in Tearfilm
Actual Study Start Date : December 28, 2020
Actual Primary Completion Date : January 22, 2021
Actual Study Completion Date : January 22, 2021

Group/Cohort Intervention/treatment
COVID-19 Positive
COVID-19 positive in nasopharyngeal swabs and tears or saliva.
Procedure: Collection of tears and saliva.
Saliva and ocular tears will be collected.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent COVID-19 testing at VUMC and tested positive.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients under 18.
  • Patients who do not speak Spanish or English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579458


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37076
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Sapna Gangaputra Vanderbilt Eye Institiute
Publications:
WHO. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases - interim guidance. 2020; 2020.

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Responsible Party: Sapna Gangaputra, Assistant Professor of Ophthalmology Co-Fellowship Director Vitreoretinal Diseases and Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04579458    
Other Study ID Numbers: 201127
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sapna Gangaputra, Vanderbilt University Medical Center:
Positive COVID 19
Ophthalmology
Eye Diseases
Additional relevant MeSH terms:
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Eye Diseases