NCT04579458

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

25 days

First QC Date

October 6, 2020

Last Update Submit

February 2, 2021

Conditions

Covid19OphthalmopathyEye Diseases

Keywords

Positive COVID 19OphthalmologyEye Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (1)

COVID-19 Positive

COVID-19 positive in nasopharyngeal swabs and tears or saliva.

Procedure: Collection of tears and saliva.

Interventions

Collection of tears and saliva.PROCEDURE

Saliva and ocular tears will be collected.

COVID-19 Positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent COVID-19 testing at VUMC and tested positive.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37076, United States

Location

Related Publications (7)

  • 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.

    PMID: 32353982BACKGROUND

  • Xie 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.

    PMID: 32355863BACKGROUND

  • Khavandi 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.

    PMID: 32354654BACKGROUND

  • 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.

    PMID: 32232433BACKGROUND

  • Lee 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.

    PMID: 24082768BACKGROUND

  • WHO. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases - interim guidance. 2020; 2020.

    BACKGROUND

  • 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.

    PMID: 32310815BACKGROUND

MeSH Terms

Conditions

COVID-19Eye Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sapna Gangaputra

    Vanderbilt Eye Institiute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology Co-Fellowship Director Vitreoretinal Diseases and Surgery

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 8, 2020

Study Start

December 28, 2020

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)