FindTrial
Sign In

SARS-CoV-2 quick analysis in breath device

Technical feasibility studies for the diagnosis of Covid-19 by rapid non-invasive test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-72bg24
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-08-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infections

Interventions

SARS CoV-2 VOC (Volatile Organic Chemicals) presence detection in samples collected from patients tested through THz spectral range characteristics (spectrum of 300–3000 GHZ) in air samples exhaled on
Device
D27.505.259.875

Sponsors

Instituto de Tecnologia do Paraná
Lead Sponsor
Tera Brasil
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Male and Female; Above 18 years old; The patient must accept and sign a form of willing and informed consent; The SARS CoV-2 carrier’s status shall be determined in a sample collected during the breath analyzed test (BAT); Outpatient cases; Symptomatic and asymptomatic.

Exclusion criteria

Exclusion criteria: Hospitalized patients; Subjects under general anesthesia; The incapacity of personally sign the consent form; The incapacity of blowing 5x in the test; BAT samples analyzed after 6h; Impossibility of obtaining a second sample; Symptomatic patients with over 5 days of symptoms for the first PCR sample or over 7 days for the repetition.

Design outcomes

Primary

MeasureTime frame
Evaluate the correlation of the 2 diagnostic methods through the ROC analysis and determination of the correlation coefficient (r).;Evaluate the sensitivity of the new method (BAT) in comparison to the gold standard (PCR).;Evaluate the specificity of the new method (BAT) in comparison with the gold standard (PCR).—

Secondary

MeasureTime frame
Assess the sensitivity of the new method (BAT) in comparison with the gold standard (PCR) in subgroups of patients: symptomatic only, only asymptomatic, by age group, by sex, according to the PCR's ct ranges.;Assess the specificity of the new method (BAT) in comparison with the gold standard (PCR) in subgroups of patients: symptomatic only, only asymptomatic, by age group, by sex, according to the PCR's ct ranges.;Perform exploratory analysis of results found in the new method (BAT) if there is identification of other respiratory viruses.—

Countries

Brazil

Contacts

Public ContactMeila Bastos de Almeida

Instituto de Tecnologia do Paraná

meilaba@tecpar.br+554133163359

Outcome results

None listed

Source: REBEC (via WHO ICTRP)