Detection of Covid-19 by Volatile Organic Compounds in Exhaled Breath (Covid-VOC)

Detection of COVID-19 by Volatile Organic Compounds in Exhaled Breath (VOCs) - a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Covid19

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L3
      • BC Cancer Research Centre
    • Vancouver, British Columbia, Canada, V5Z 1L3
      • British Columbia Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect breath samples from Covid-19 positive patients at time of diagnosis and post recovery	This is an exploratory trial. The target VOCs are not known at this time. The same patient will be there own control to identify VOCs specific to SARS-CoV-2 viral infection. The presence and absence of VOCs post recovery will indicate the outcome measure.	6 months

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency
• Investigators: Principal Investigator: Renelle Myers, MD, BCCA, Part of the Provincial Health Services Authority

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Anticipated): May 5, 2021
• Study Completion (Anticipated): May 5, 2021

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: H20-01234

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No