Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 2:11 PM
Study NCT ID:
NCT04374656
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2020-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis During the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D003236', 'term': 'Conjunctivitis, Viral'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Conjunctival, nasal, and nasopharyngeal swabs will be taken for PCR testing and next-generation sequencing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of conjunctival samples tested positive for SARS-CoV-2', 'timeFrame': '1 year', 'description': 'Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples'}], 'secondaryOutcomes': [{'measure': 'Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples', 'timeFrame': '1 year', 'description': 'Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR'}, {'measure': 'Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples', 'timeFrame': '1 year', 'description': 'Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR'}, {'measure': 'Rate of development of COVID-19 in the study patient population', 'timeFrame': '1 year', 'description': 'Number of patients developed COVID-19 divided by the number of the study population'}, {'measure': 'Positive conjunctival sample rate in patient developed COVID-19', 'timeFrame': '1 year', 'description': 'Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['conjunctivitis', 'SARS-CoV-2', 'COVID-19', 'Ocular Infection', 'viral conjunctivitis', 'ocular inflammation', 'conjunctival swab', 'PCR'], 'conditions': ['Conjunctivitis', 'SARS-CoV-2', 'COVID-19', 'Ocular Infection, Viral', 'Ocular Inflammation']}, 'descriptionModule': {'briefSummary': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients present or are referred to the ophthalmology clinic due to red eye complaints, suspected viral conjunctivitis, or keratoconjunctivitis will be consecutively approached and recruited if they show a willingness to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years old or older\n* Willingness to participate\n* Presents with red eye complaint\n\nExclusion Criteria:\n\n* Adults lacking capacity to consent\n* Adults with special needs due to physical, medical, developmental or cognitive conditions'}, 'identificationModule': {'nctId': 'NCT04374656', 'briefTitle': 'Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis During the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients Presenting With Conjunctivitis to the Ophthalmology Clinics During the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'IRB00249598'}}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Sezen Karakus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wilmer Eye Institute at Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}