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Medical device clinical trial on Covid 19 patients.

An Open Label, Proof of Concept, Single Center, Comparative Study of a Non-Invasive Breath Sampling Device for providing samples useful in the diagnosis of COVID-19.

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/06/034470
Enrollment
40
Registered
2021-06-30
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: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

StanwixForbes LLC
Lead Sponsor
Kamineni Life Sciences Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, 18 to 75 years of age (both inclusive). 2. Patients with clinical symptoms of SARS-CoV-2. 3. Willing to come for follow â??up visit. 4. Able to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Volunteers who are in ICU or unconscious or unable to give breath samples. 2. History of having received or participated in any other similar clinical trial in the last 24 hrs or currently ongoing. 3. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study.

Design outcomes

Primary

MeasureTime frame
1. % difference in the positivity or negativity of the COVID-19 results between invasive and non-invasive sample testing/ diagnosis. 2. % difference in the viral load of the COVID-19 samples between invasive and non-invasive breath sample testing/ diagnosis using RT-PCR method. Timepoint: Day 0 and Day 7 or Date of discharge

Secondary

MeasureTime frame
â?¢ Volunteersâ?? feedback on the non-invasive breath sampling device compared to the invasive testing method using a feedback questionnaireTimepoint: Day 0 and Day 7 or Date of discharge

Countries

India

Contacts

Public ContactAndrew Ganesh

StanwixForbes LLC

AndrewG@stanwixforbes.com

Outcome results

None listed

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