Clinical trial NCT05438589: Novel Rapid POC Diagnostics for COVID-19
Official title: Evaluation of the Performance of Novel Rapid Diagnostics for SARS-CoV-2 at Point-of-care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 1283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines) presenting at the testing site(s) will be invited to participate. Each participant will have two respiratory swabs collected: one for RT-PCR testing and diagnosis, paired with a second swab to be used on the index Ag RDT. In order to meet the study objectives, two different population groups will be considered:

1. SYMPTOMATIC: Individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO guidelines) and presenting at the testing site(s) with symptoms of COVID-19.
2. ASYMPTOMATIC: Individuals (≥ 18 years old) at risk of COVID-19 (as per national or WHO guidelines) and presenting at the testing site(s) with no symptoms of COVID-19

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 nasal swabs and saliva samples from participants suspected to have Covid-19 infection (with or without symptoms). The study will last approximately 9 months.

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 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.

Eligibility criteria: Inclusion Criteria:

* ≥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 Criteria:

* 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

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: at enrolment
Secondary outcomes:
measure: Sensitivity and specificity in specific subgroups
timeFrame: at enrolment
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: National Center for Disease Control
city: Johannesburg
country: South Africa
facility: Ezintsha
Study officials:
affiliation: Find
name: Elena Ivanova Reipold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: