Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04579458
Status:
WITHDRAWN
Last Update Posted:
2021-02-05
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of COVID-19 in Tearfilm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not able to enroll the amount required.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Co-relation of COVID-19 activity', 'timeFrame': '3 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positive COVID 19', 'Ophthalmology', 'Eye Diseases'], 'conditions': ['Covid19', 'Ophthalmopathy', 'Eye Diseases']}, 'referencesModule': {'references': [{'pmid': '32353982', 'type': 'BACKGROUND', '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):1269. doi: 10.3390/jcm9051269."}, {'pmid': '32355863', 'type': 'BACKGROUND', '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.'}, {'pmid': '32354654', 'type': 'BACKGROUND', 'citation': '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': '32232433', 'type': 'BACKGROUND', 'citation': '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': '24082768', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'WHO. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases - interim guidance. 2020; 2020.'}, {'pmid': '32310815', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMethodology: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent COVID-19 testing at VUMC and tested positive.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Patients under 18.\n* Patients who do not speak Spanish or English'}, 'identificationModule': {'nctId': 'NCT04579458', 'briefTitle': 'Assessment of COVID-19 in Tearfilm', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Assessment of COVID (Coronavirus Disease)-19 in Tearfilm', 'orgStudyIdInfo': {'id': '201127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Positive', 'description': 'COVID-19 positive in nasopharyngeal swabs and tears or saliva.', 'interventionNames': ['Procedure: Collection of tears and saliva.']}], 'interventions': [{'name': 'Collection of tears and saliva.', 'type': 'PROCEDURE', 'description': 'Saliva and ocular tears will be collected.', 'armGroupLabels': ['COVID-19 Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37076', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Sapna Gangaputra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt Eye Institiute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology Co-Fellowship Director Vitreoretinal Diseases and Surgery', 'investigatorFullName': 'Sapna Gangaputra', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}