Genosvid Diagnostic Test for Early Detection of COVID-19

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Other: exhaled breath sampling

• Registration Number: NCT04558372
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Status Verified: 2020-12
• Primary Completion: 2020-12-12
• Study Completion: 2020-12-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1999

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1- 43 COVID-19 patients	exhaled breath sampling	COVID-19 patients breath normally via disposable non-rebreathing mask
Group 2- 40 non COVID-19 patients	exhaled breath sampling	Non COVID-19 patients breath normally via disposable non-rebreathing mask
Group 3- suspected COVID-19 patients	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of electronic nose signal in COVID-19	2 years	sensitivity, specificity, positive predictive value, negative predictive value of electronic nose signal in diagnosing COVID-19

Trial Locations

Locations (8)

RS Bhayangkara Tk I R.Said Soekanto; 🇮🇩 Jakarta, Indonesia

Saiful Anwar; 🇮🇩 Malang, Indonesia

Bambanglipuro Hospital; 🇮🇩 Yogyakarta, Indonesia

Dr Sardjito Hospital; 🇮🇩 Yogyakarta, Indonesia

Bhayangkara Tk III Polda DIY; 🇮🇩 Yogyakarta, Indonesia

RS Akademik UGM; 🇮🇩 Yogyakarta, Indonesia

RSPAU Hardjolukito; 🇮🇩 Yogyakarta, Indonesia

RST Tk III Dr Soetarto; 🇮🇩 Yogyakarta, Indonesia