Covid19 Clinical Trial
Official title:
Assessment of COVID (Coronavirus Disease)-19 in Tearfilm
NCT number | NCT04579458 |
Other study ID # | 201127 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | December 28, 2020 |
Est. completion date | January 22, 2021 |
Verified date | February 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 22, 2021 |
Est. primary completion date | January 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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. — View Citation
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. — View Citation
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). pii: E1269. doi: 10.3390/jcm9051269. — View Citation
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. — View Citation
WHO. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases - interim guidance. 2020; 2020.
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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