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

NCT04714333 | Unknown

• 1 other identifier: H20-01234
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (2)

BC Cancer Research Centre

Vancouver, British Columbia, V5Z 1L3, Canada

Location

British Columbia Research Centre

Vancouver, British Columbia, V5Z 1L3, Canada

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Renelle Myers, MD

  BCCA, Part of the Provincial Health Services Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: May 6, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

CA (2)