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COVID-19NCT04558372

Genosvid Diagnostic Test for Early Detection of COVID-19

A study testing exhaled breath sampling in people with COVID-19, run by Gadjah Mada University at 8 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 years and older
Conditions the study is for
COVID-19
What is being tested?
exhaled breath sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,999 participants
Where
8 sitesIndonesia
Study dates
1 Apr 2020to 12 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Indonesia8 sites

  • RS Bhayangkara Tk I R.Said Soekanto

    Jakarta

  • Saiful Anwar

    Malang

  • Dr Sardjito Hospital

    Yogyakarta, 55281

  • Bambanglipuro Hospital

    Yogyakarta, 55764

  • Bhayangkara Tk III Polda DIY

    Yogyakarta

  • RS Akademik UGM

    Yogyakarta

  • RSPAU Hardjolukito

    Yogyakarta

  • RST Tk III Dr Soetarto

    Yogyakarta

Other trials in Indonesia

About this study

Official title: Genosvid Diagnostic Test for Early Detection of COVID-19: UGM Electronic-Nose Innovation for Indonesia

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.

Read the 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.

Conditions
COVID-19
Being tested
exhaled breath sampling
Keywords
COVID-19, diagnosis, electronic nose
Medical subject headings
COVID-19, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exhaled breath samplingOther

    Also called GENOSVID portable 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.

  • exhaled breath samplingOther

    Also called GENOSVID portable 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.

  • exhaled breath samplingOther

    Also called GENOSVID portable 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.

Study groups in NCT04558372
Study groupRoleWhat they receive
Group 1- 43 COVID-19 patientsExperimentalCOVID-19 patients breath normally via disposable non-rebreathing mask
Receives: Other: exhaled breath sampling
Group 2- 40 non COVID-19 patientsExperimentalNon COVID-19 patients breath normally via disposable non-rebreathing mask
Receives: Other: exhaled breath sampling
Group 3- suspected COVID-19 patientsExperimentalThe 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.
Receives: Other: exhaled breath sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy of electronic nose signal in COVID-19

    sensitivity, specificity, positive predictive value, negative predictive value of electronic nose signal in diagnosing COVID-19

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start1 Apr 2020
  3. Primary completion12 Dec 2020
  4. Study completion12 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Model description
3 groups: 1. COVID-19 patients 2. non COVID-19 patients 3. suspected COVID-19 patients
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,999 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558372
Sponsor's protocol ID
1.6/2020
Status last verified
Dec 2020
First submitted
20 Sep 2020
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35659391

Questions about this trial

What is this clinical trial studying?

A study testing exhaled breath sampling in people with COVID-19, run by Gadjah Mada University at 8 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of electronic nose signal in COVID-19 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04558372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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