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Clinical Trials/NCT05162495
NCT05162495
Unknown
Not Applicable

A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.

Tera Group0 sites500 target enrollmentJanuary 1, 2022
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ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Tera Group
Enrollment
500
Primary Endpoint
Primary Outcome Measure
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

Detailed Description

According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples. The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements. Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples. The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
August 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Tera Group
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Male or female subject aged 18 years and above
  • •Subject is able and willing to provide informed consent
  • •Subject is able to complete the breath test.
  • •Requiring a diagnostic or screening RT-PCR test for COVID-
  • •Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Exclusion Criteria

  • •Male of female subject under the age of
  • •Subject is unable to provide and informed consent, for any reason.

Outcomes

Primary Outcomes

Primary Outcome Measure

Time Frame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample

Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.

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