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Genosvid Diagnostic Test for Early Detection of COVID-19

NCT ID: NCT04558372

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-12-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Keywords

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COVID-19 diagnosis electronic nose

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

3 groups:

1. COVID-19 patients
2. non COVID-19 patients
3. suspected COVID-19 patients
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Group 1- 43 COVID-19 patients

COVID-19 patients breath normally via disposable non-rebreathing mask

Group Type EXPERIMENTAL

exhaled breath sampling

Intervention Type OTHER

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.

Group 2- 40 non COVID-19 patients

Non COVID-19 patients breath normally via disposable non-rebreathing mask

Group Type EXPERIMENTAL

exhaled breath sampling

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

exhaled breath sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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GENOSVID portable exhaled breath sampling GENOSVID portable exhaled breath sampling GENOSVID portable exhaled breath sampling

Eligibility Criteria

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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).
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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dr. Dian K. Nurputra, M.Sc, Ph.D, SpA

MD(Paed), M.Sc, Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dian K. Nurputra, MD(Paed), M.Sc, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

Kuwat Triyana, Prof, Dr.Eng, MSi.

Role: STUDY_CHAIR

Faculty of Mathematics and Natural Sciences Universitas Gadjah Mada

Locations

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RS Bhayangkara Tk I R.Said Soekanto

Jakarta, , Indonesia

Site Status

Saiful Anwar

Malang, , Indonesia

Site Status

Dr Sardjito Hospital

Yogyakarta, , Indonesia

Site Status

Bambanglipuro Hospital

Yogyakarta, , Indonesia

Site Status

Bhayangkara Tk III Polda DIY

Yogyakarta, , Indonesia

Site Status

RS Akademik UGM

Yogyakarta, , Indonesia

Site Status

RSPAU Hardjolukito

Yogyakarta, , Indonesia

Site Status

RST Tk III Dr Soetarto

Yogyakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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Hidayat SN, Julian T, Dharmawan AB, Puspita M, Chandra L, Rohman A, Julia M, Rianjanu A, Nurputra DK, Triyana K, Wasisto HS. Hybrid learning method based on feature clustering and scoring for enhanced COVID-19 breath analysis by an electronic nose. Artif Intell Med. 2022 Jul;129:102323. doi: 10.1016/j.artmed.2022.102323. Epub 2022 May 17.

Reference Type DERIVED
PMID: 35659391 (View on PubMed)

Other Identifiers

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1.6/2020

Identifier Type: -

Identifier Source: org_study_id