- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558372
Genosvid Diagnostic Test for Early Detection of COVID-19
Genosvid Diagnostic Test for Early Detection of COVID-19: UGM Electronic-Nose Innovation for Indonesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The validation of device is conducted to 43 confirmed COVID-19 patients and 40 confirmed COVID-19 negative patients from Bhayangkara Hospital, RSLKC Bambalipuro in Yogyakarta Special Region, Indonesia.
Afterwards, patients with symptoms suggesting COVID-19 will be recruited using multicentre consecutive sampling. The minimum number of participants required is 1460 subjects. The study use a triple-blind design where the research subjects, breath sample takers, and sample examiners did not know the results of each sampling that had been done. The final data processor was also blinded to the results of nose and throat swabs. The breath sampling data is saved in graphic form which interpretation will be carried out later by the data processor at the final stage.
This study population involve children and adults who come to the COVID-19 outpatient clinic in each participating hospital with a diagnosis of suspected COVID-19 infection. All patients remain in the setting under medical service in accordance with the standard operating procedure (SOP) and clinical practice guidelines (CPG) protocols for handling patients with suspected COVID-19. The patients underwent nasal and oropharyngeal swabs according to the COVID-19 outpatient CPG.
The participants will be asked about symptoms that they have, such as fever, fatigue, dry cough, stuffy/ runny nose, sore throat, myalgia, shortness of breath, and diarrhea. Afterwards, they will be asked to breathe normally using a mask for 2 times, then inhale and exhale in a forced expiratory volume to an air collecting bag that later is connected to the e-nose machine via a HEPA-filter. The performance of breath test will be compared with the performance of symptoms with the reference of RT-PCR results. In addition, participants' demographic and clinical data will be collected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Jakarta, Indonesia
- RS Bhayangkara Tk I R.Said Soekanto
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Malang, Indonesia
- Saiful Anwar
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Yogyakarta, Indonesia, 55281
- Dr Sardjito Hospital
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Yogyakarta, Indonesia, 55764
- Bambanglipuro Hospital
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Yogyakarta, Indonesia
- Bhayangkara Tk III Polda DIY
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Yogyakarta, Indonesia
- RS Akademik UGM
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Yogyakarta, Indonesia
- RSPAU Hardjolukito
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Yogyakarta, Indonesia
- RST Tk III Dr Soetarto
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with COVID-19, non COVID-19, and suspected COVID-19 infection, based on the results of anamnesis, physical examination, laboratory, X-rays and rapid tests.
- Able to produce samples for RT-PCR examination.
- Agree to participate (sign informed consent). For children, informed consent are obtained from the parents. For adolescent patients, accent consent is asked.
- Patients who do not need oxygen therapy supplementation in the form of mask-type or ventilator. Patients who use oxygen supplementation with nasal cannula are still included as study participants.
Exclusion Criteria:
- Unable to breath deeply due to difficulty breathing due to complications of COVID-19 or other diseases
- The quality of the breath do not meet the standard interpretation of the instrument sensor curve (breath sampel is declared invalid).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1- 43 COVID-19 patients
COVID-19 patients breath normally via disposable non-rebreathing mask
|
The participants breath through non-rebreathing mask until the reservoir bag is full.
The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
Other Names:
The participants breath normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume through an e-nose tube connected to the Hepa-filter at the inlet.
Other Names:
|
Experimental: Group 2- 40 non COVID-19 patients
Non COVID-19 patients breath normally via disposable non-rebreathing mask
|
The participants breath through non-rebreathing mask until the reservoir bag is full.
The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
Other Names:
The participants breath normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume through an e-nose tube connected to the Hepa-filter at the inlet.
Other Names:
|
Experimental: Group 3- suspected COVID-19 patients
The participants breath normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume through an e-nose tube connected to the Hepa-filter at the inlet.
|
The participants breath through non-rebreathing mask until the reservoir bag is full.
The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
Other Names:
The participants breath normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume through an e-nose tube connected to the Hepa-filter at the inlet.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of electronic nose signal in COVID-19
Time Frame: 2 years
|
sensitivity, specificity, positive predictive value, negative predictive value of electronic nose signal in diagnosing COVID-19
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dian K. Nurputra, MD(Paed), M.Sc, Ph.D, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
- Study Chair: Kuwat Triyana, Prof, Dr.Eng, MSi., Faculty of Mathematics and Natural Sciences Universitas Gadjah Mada
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.6/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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