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The performance of a novel ultra-rapid diagnostic test in the detection of COVID 19, an observational and case controlled study.

A Pivotal Study of ASU CV19 In COVID-19 Positive Patients and Healthy Subjects

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/11/029037
Enrollment
750
Registered
2020-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: ASU Device: Patient breathes into device by themselves after instruction by research assistant with regular respirations over a minimum 3-5 minutes providing approximately 60-100 respir

Sponsors

Canary Health Technologies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, Adult over the age of 18 No smoking, eating or alcohol for 4 hours prior to test Either COVID-19 Positive or COVID-19 Negative No perfume/cologne or heavy scent Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigatorâ??s discretion Able (in the Investigators opinion) and willing to comply with all study requirements. Diagnosed with required disease/severity/symptoms, or, if healthy volunteer study: beingood health

Exclusion criteria

Exclusion criteria: Age Any serious injury or illness likely to preclude completion of the trial. Frequent alcohol or recreational drug use. Hospitalized. Undergoing active chemotherapy. Fever in uninfected controls. Hypoxia, defined as pulse oximetry lower than 92% (90% in smokers and those with chronic lung disease). Respiratory disease such as COPD and Asthma. Currently taking any corticosteroid treatment including but not limited to oral and inhaled corticosteroid (within 4 weeks of trial). Inability to give informed consent and/or has no guardian. Flu shot within 6-8 weeks of test.

Design outcomes

Primary

MeasureTime frame
To collect breath sample from uninfected subjects and those diagnosed with COVID 19 and compare the VOC pattern in each group to develop an algorithm for analysisTimepoint: At the end of the Study

Secondary

MeasureTime frame
To test the large group of COVID 19 positive and negative patients to develop the AI pattern-recognition program and to ascertain the test characteristics of the deviceTimepoint: At the end of the study

Countries

India

Contacts

Public ContactProf Ashok Rattan

Divoc Laboratories

drashokrattan@gmail.com9560272576

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026