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Clinical trial to assess the rapid diagnostic test for detecting SARS-CoV-2 through breath analysis

Multicenter, adaptive, and single-blind clinical trial to assess the predictive value of the rapid diagnostic test for detecting SARS-CoV-2 through breath analysis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-664747m
Enrollment
Unknown
Registered
2022-02-18
Start date
2021-11-01
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 Infection

Interventions

Research participants suspected of coronavirus infection will be included in the study and after meeting the eligibility criteria and signing the consent/assent form, they will have the expired air sa

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
BOH Brasil Serviços Diagnósticos Ltda
Collaborator

Eligibility

Age
8 Years to No maximum

Inclusion criteria

Inclusion criteria: Both genders; Age higher or equal to 08 years completed at inclusion; Subjects to be tested for SARS-CoV-2 infection by RT-PCR or with collection of the RT-PCR test or Viral Panel and BOH within 48h between them.

Exclusion criteria

Exclusion criteria: Inability to fill the air bag; Persons under guardianship or deprived of liberty; Acute Obstructive Pulmonary Disease, which makes it impossible to fill the air bag.

Design outcomes

Primary

MeasureTime frame
The results and outcomes of patients admitted to research centers in the Brazil are as follows: results are higher or equal to 90 percent negative predictive value (NPV) correlation with RT-PCR test and higher or equal to 90 percent positive predictive value (PPV) correlation with RT-PCR test.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactAndréa Martinez

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

amartinez@atlantisclinical.com+55 11 5093-1986

Outcome results

None listed

Source: REBEC (via WHO ICTRP)