Study to prove the use of Svasth Viral detection scanner using Near Infrared technology for Covid-19 detection and Viral load without taking Nasal or mouth swab or even blood sample.Comparing the results with RT-PCR results which is the current gold standard in Covid-19 detection.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J988- Other specified respiratory disordersHealth Condition 3: J988- Other specified respiratory disordersHealth Condition 4: B999- Unspecified infectious disease
- Registration Number
- CTRI/2021/01/030661
- Lead Sponsor
- Miisky Technovation Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Age 25-80 years (both inclusive) at the time of signing ICF
2 Patients who have tested positive for RT-PCR testing & are undergoing treatment as inpatients
3 Voluntarily participating in the clinical study fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
4 Patients who have tested negative for RT-PCR testing either for initial detection or post Covi-19 treatment
1 Participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
2 Cross reactive viral positive for HIV, HbsAg, NL-63, CoV1.
3 Pregnant & Lactating women.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Calibration of Svasth Viral Detection device with RT-PCR-CT values for positive & Negative Covid-19 patients <br/ ><br> <br/ ><br>2 Predict Viral Load based on the MLR algorithm of the Near Infra Red sensors combination <br/ ><br> <br/ ><br>3 Improvise the prediction and algorithm and continue prediction on of Covid-19 positive and negative patients <br/ ><br>Timepoint: Outcome 1 3 WEEKS <br/ ><br>Outcome 2 6 WEEKS <br/ ><br>Outcome 3 12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method To predict Covid-19 results comparable to RT-PCR results in patients on Rapid scaleTimepoint: 12 WEEKS