Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1283 participants
OBSERVATIONAL
2022-04-25
2023-02-28
Brief Summary
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Detailed Description
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Enrolled participants will be asked to provide 2 samples: one nasopharyngeal swab that will be utilized for Covid-19 diagnosis by standard PCR and one sample (either nasal swab or saliva) to be used for the new antigen rapid diagnostic test under evaluation. At least 2 different antigen tests will be evaluated to determine sensitivity and specificity: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Jiangsu Bioperfectus Technologies) and GeneFinder COVID-19 Ag Rapid test (Osang Healthcare).
The data gathered from this study, could be used as part of the dossier to be submitted to WHO (world health organization) for review.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Presenting to testing locations linked to the clinical sites
* Suspected to have COVID-19 (as per WHO or national guidelines). These include the following groups:
* Individuals with acute onset of any of the following signs or symptoms: fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting, diarrhoea, altered mental status (for SYMPTOMATIC group);
* Contacts of confirmed cases of COVID-19
* Individuals residing or working in an area with high risk of transmission of virus
* Individuals residing or travelling to an area with community transmission
* Individuals working in any health care setting, including within health facilities or within the community
* Provided voluntary written consent to participate in this study
* Provided a specimen suitable for testing
Exclusion Criteria
* Individuals on oxygen therapy
* Recent history of excessive nose bleeds
* Individuals unable to give informed consent
* Hemodynamic instability as determined by the treating physician
18 Years
100 Years
ALL
No
Sponsors
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Foundation for Innovative New Diagnostics, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Elena Ivanova Reipold, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Find
Locations
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National Center for Disease Control
Tbilisi, , Georgia
Ezintsha
Johannesburg, , South Africa
Countries
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Other Identifiers
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CV008
Identifier Type: -
Identifier Source: org_study_id