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Device validation study for detecting COVID-19

A prospective, open-label, comparative study of non-invasive diagnostic test platform TruCov based three products with invasive oral/nasal swab RTPCR method for the diagnosis of Covid-19 infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039845
Enrollment
100
Registered
2022-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: TruCov based three products 1. TruCov-Breath 2. TruCov-Saliva 3. TruCov-Flow: This is a diagnostic validation study, way we do testing for COVID-19 within 15-30 seconds using breath (C

Sponsors

Neuome Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged 05-75 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. Mild to moderate COVID-19 clinical symptoms and not confirmed by the any current recommended COVID-19 test 4. Can take oral medicines 5. Subject willing to abide by and comply with the study protocol

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 patientââ?¬•s inclusion for the study

Design outcomes

Primary

MeasureTime frame
� Development of all the parameters including sensitivity and specificity � Percentage difference in the positivity and negativity of COVID-19 results between Invasive and non-invasive COVID-19 testing method Timepoint: Base line and day 3

Secondary

MeasureTime frame
� Design and development of assay instrument. � Clinical sensitivity and specificity Timepoint: Base line and Day 3

Countries

India

Contacts

Public ContactDr Rajani Kanth Vangala

Research Consultancy

dralbens@myrescon.com8884431444

Outcome results

None listed

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