Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04558372 |
Other study ID # |
1.6/2020 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2020 |
Est. completion date |
December 12, 2020 |
Study information
Verified date |
December 2020 |
Source |
Gadjah Mada University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.