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Assessment of COVID-19 in Tearfilm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Not able to enroll the amount required.)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

Tracking Information
First Submitted Date October 6, 2020
First Posted Date October 8, 2020
Last Update Posted Date February 5, 2021
Actual Study Start Date December 28, 2020
Actual Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2020)
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.
Original Primary Outcome Measures
 (submitted: October 6, 2020)
Rationale and Specific Aims [ Time Frame: 3 months ]
The aim is to assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of COVID-19 in Tearfilm
Official Title Assessment of COVID (Coronavirus Disease)-19 in Tearfilm
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who underwent COVID-19 testing at VUMC and tested positive.
Condition
  • Covid19
  • Ophthalmopathy
  • Eye Diseases
Intervention Procedure: Collection of tears and saliva.
Saliva and ocular tears will be collected.
Study Groups/Cohorts COVID-19 Positive
COVID-19 positive in nasopharyngeal swabs and tears or saliva.
Intervention: Procedure: Collection of tears and saliva.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: February 2, 2021)
0
Original Estimated Enrollment
 (submitted: October 6, 2020)
500
Actual Study Completion Date January 22, 2021
Actual Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04579458
Other Study ID Numbers 201127
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Sapna Gangaputra, Vanderbilt University Medical Center
Original Responsible Party Same as current
Current Study Sponsor Vanderbilt University Medical Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Sapna Gangaputra Vanderbilt Eye Institiute
PRS Account Vanderbilt University Medical Center
Verification Date February 2021