Genosvid Diagnostic Test for Early Detection of COVID-19

NCT04558372 | Completed

• 1 other identifier: 1.6/2020
• Study Type: interventional
• Target: 1,999
• Locations: 1 country
• Sites: 8

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.

Conditions

COVID-19

Keywords

COVID-19; diagnosis; electronic nose

Outcome Measures

Primary Outcomes (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

  2 years

Study Arms (3)

Group 1- 43 COVID-19 patients

EXPERIMENTAL

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

Other: exhaled breath sampling

Group 2- 40 non COVID-19 patients

EXPERIMENTAL

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

Other: exhaled breath sampling

Group 3- suspected COVID-19 patients

EXPERIMENTAL

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

Interventions

exhaled breath sampling 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.

Also known as: GENOSVID portable exhaled breath sampling

Group 1- 43 COVID-19 patients

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (8)

RS Bhayangkara Tk I R.Said Soekanto

Jakarta, Indonesia

Location

Saiful Anwar

Malang, Indonesia

Location

Dr Sardjito Hospital

Yogyakarta, 55281, Indonesia

Location

Bambanglipuro Hospital

Yogyakarta, 55764, Indonesia

Location

Bhayangkara Tk III Polda DIY

Yogyakarta, Indonesia

Location

RS Akademik UGM

Yogyakarta, Indonesia

Location

RSPAU Hardjolukito

Yogyakarta, Indonesia

Location

RST Tk III Dr Soetarto

Yogyakarta, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 35659391 DERIVED

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

  PRINCIPAL INVESTIGATOR

• Kuwat Triyana, Prof, Dr.Eng, MSi.

  Faculty of Mathematics and Natural Sciences Universitas Gadjah Mada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD(Paed), M.Sc, Ph.D

Model Details: 3 groups: 1. COVID-19 patients 2. non COVID-19 patients 3. suspected COVID-19 patients

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 22, 2020
• Study Start: April 1, 2020
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (8)