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Genosvid Diagnostic Test for Early Detection of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558372
Recruitment Status : Completed
First Posted : September 22, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Dian K. Nurputra, M.Sc, Ph.D, SpA, Gadjah Mada University

Brief Summary:
Electronic-nose had been used to diagnose other infectious lung diseases, such as tuberculosis. Universitas Gadjah Mada has developed an electronic-nose device which is easy-to-use, portable, and can be manufactured at a low price. Here the investigators test the electronic-nose to diagnose COVID-19 in Indonesia.

Condition or disease Intervention/treatment Phase
COVID-19 Other: exhaled breath sampling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1999 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

3 groups:

  1. COVID-19 patients
  2. non COVID-19 patients
  3. suspected COVID-19 patients
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The person who operates breath test is blinded to the results of swab. The swab taker is blinded to the result of breath sample. The patients also do not know the results of the interpretation of the breath sample. Patients will receive information on the results of the oro/ nasopharyngeal swab in accordance with the COVID-19 health service standards. The final data processor is 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.
Primary Purpose: Diagnostic
Official Title: Genosvid Diagnostic Test for Early Detection of COVID-19: UGM Electronic-Nose Innovation for Indonesia
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : December 12, 2020
Actual Study Completion Date : December 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1- 43 COVID-19 patients
COVID-19 patients breath normally via disposable non-rebreathing mask
Other: exhaled breath sampling
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 Name: GENOSVID portable exhaled breath sampling

Experimental: Group 2- 40 non COVID-19 patients
Non COVID-19 patients breath normally via disposable non-rebreathing mask
Other: exhaled breath sampling
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 Name: GENOSVID portable exhaled breath sampling

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.
Other: exhaled breath sampling
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 Name: GENOSVID portable exhaled breath sampling




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558372


Locations
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Indonesia
RS Bhayangkara Tk I R.Said Soekanto
Jakarta, Indonesia
Saiful Anwar
Malang, Indonesia
Dr Sardjito Hospital
Yogyakarta, Indonesia, 55281
Bambanglipuro Hospital
Yogyakarta, Indonesia, 55764
Bhayangkara Tk III Polda DIY
Yogyakarta, Indonesia
RS Akademik UGM
Yogyakarta, Indonesia
RSPAU Hardjolukito
Yogyakarta, Indonesia
RST Tk III Dr Soetarto
Yogyakarta, Indonesia
Sponsors and Collaborators
Gadjah Mada University
Investigators
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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
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Responsible Party: dr. Dian K. Nurputra, M.Sc, Ph.D, SpA, MD(Paed), M.Sc, Ph.D, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT04558372    
Other Study ID Numbers: 1.6/2020
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. Dian K. Nurputra, M.Sc, Ph.D, SpA, Gadjah Mada University:
COVID-19
diagnosis
electronic nose
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases