Status:
COMPLETED
Novel Rapid POC Diagnostics for COVID-19
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Conditions:
COVID-19 Respiratory Infection
Eligibility:
All Genders
18-100 years
Brief Summary
This is a prospective, multicentre study in which the diagnostic accuracy of multiple Covid-19 Antigen rapid diagnostic tests will be assessed for COVID-19 case detection using prospectively collected...
Detailed Description
Adult individuals with presumptive Covid-19, either symptomatic or asymptomatic, will be screened for inclusion at 4 different study sites located in Georgia and South Africa. Enrolled participants w...
Eligibility Criteria
Inclusion
- ≥18 years of age
- 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
- Individuals unable to cooperate with respiratory sample collection
- Individuals on oxygen therapy
- Recent history of excessive nose bleeds
- Individuals unable to give informed consent
- Hemodynamic instability as determined by the treating physician
Key Trial Info
Start Date :
April 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
1283 Patients enrolled
Trial Details
Trial ID
NCT05438589
Start Date
April 25 2022
End Date
February 28 2023
Last Update
December 1 2023
Active Locations (2)
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1
National Center for Disease Control
Tbilisi, Georgia
2
Ezintsha
Johannesburg, South Africa