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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
British Columbia
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Vancouver、British Columbia、カナダ、V5Z 1L3
- BC Cancer Research Centre
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Vancouver、British Columbia、カナダ、V5Z 1L3
- British Columbia Research Centre
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Collect breath samples from Covid-19 positive patients at time of diagnosis and post recovery
時間枠:6 months
|
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
|
協力者と研究者
捜査官
- 主任研究者:Renelle Myers, MD、BCCA, Part of the Provincial Health Services Authority
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H20-01234
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。