Clinical trial NCT04714333: Detection of Covid-19 by Volatile Organic Compounds in Exhaled Breath
Official title: Detection of COVID-19 by Volatile Organic Compounds in Exhaled Breath (VOCs) - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the COVID wards at VGH, all patients admitted will be given a letter of invite on admission if eligible and if interested and eligible will be enrolled. Consenting patients and breath collection will be performed in the patients' hospital room with proper personnel protective equipment. A verbal consent will be collected as to not contaminate consent forms. We aim to recruit up to 20 patients.

Additional participants will be recruited from community testing sites. Participants will be approached to be invited to participate while waiting in their vehicles at the drive-by testing sites. If time permits consent and breath collection will be performed while they wait in line. If there is a minimal line up, participant's breath will be collected.

Brief summary: Our primary aim is to collect breath samples from COVID-19 positive patients at the time of diagnosis, during and after recovery using the same patient as his/her own control to identify VOCs specific to SARS-COV-2 viral infection. A secondary aim is to determine the patient's likely disease trajectory in terms of recovery versus progression to respiratory and or multi-organ failure.

Breath samples will be collected as soon as the patient is admitted to the Vancouver General Hospital COVID Ward with a diagnosis of COVID-19 by RT-PCR in nasopharyngeal/throat swab. A second breath sample will be obtained one week later, or before hospital discharge or if they become sicker prior to transfer to the intensive care. A third sample will be taken to 8-12 weeks after recovery from the illness with a negative COVID-19 RT-PCR test. VOCs in exhaled breath will be measured by gas chromatography-mass spectrometry (GC-TOF-MS or GCxGC-TOFMS). VOC profiles from the symptomatic phase and recovery phase will be compared to determine if there are unique VOCs associated with COVID-19 infection. Comparison of VOC profiles between those who recover and those who progressed will provide information on potential prognostic features. The results of this pilot study will form the basis to determine if a larger study is warranted.

Detailed description: Patients will be recruited from the COVID wards at VGH, all patients admitted will be given a letter of invite on admission if eligible and if interested and eligible will be enrolled. Sample for the study will be collected at the VGH COVID patient wards. Consenting patients and breath collection will be performed in the patients' hospital room with proper personnel protective equipment. A verbal consent will be collected as to not contaminate consent forms. A paper copy will be given or emailed to the participants to have for their own records. .We aim to recruit up to 20 patients. The final number will be dependent on the number of new cases in Vancouver available for the study after REB approval.

Additional participants will be recruited from community testing sites. Participants will be approached to be invited to participate while waiting in their vehicles at the drive-by testing sites.

Breath samples will be analyzed on a SepSolve GC-TOF MS system at the BC Cancer Research Institute.

Eligibility criteria: Inclusion Criteria:

* Are between the ages of 18 and 85 years
* Are test positive for COVID-19 (SARS-CoV-2)
* Are capable of providing informed consent to participate in the study

Exclusion Criteria:

* Too sick to provide a breath sample
* Unwilling to sign a consent
* Unwilling to be followed up after you have recovered from the illness.

Primary outcomes:
measure: Collect breath samples from Covid-19 positive patients at time of diagnosis and post recovery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Research Centre
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Research Centre
state: British Columbia
Study officials:
affiliation: BCCA, Part of the Provincial Health Services Authority
name: Renelle Myers, MD
role: PRINCIPAL_INVESTIGATOR
References: