CoronavirusNCT04320056
Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)
A study testing Standard administration of oxygen flow and Automated oxygen administration - FreeO2 in people with Coronavirus and Pneumonia, run by Laval University at 1 site in Canada.
Trial summary
There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, Pneumonia, Oxygen Toxicity
- What is being tested?
- Standard administration of oxygen flow and Automated oxygen administration - FreeO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years old
- patients with acute respiratory failure related to suspected community acquired pneumonia (viral and non viral) requiring oxygen therapy < 6 L/min (or FiO2< 0.50) (to maintain SpO2 between 90 and 94% SpO2) without criteria for immediate intubation or ICU transfer.
- Patients hospital admission < 72 hours
Who cannot join
- shock state,
- no SpO2 signal available,
- patient agitation,
- pH < 7.30 (if blood gas available)
- PaCO2 > 50 mmHg, (if blood gas available) or chronic hypercapnia history
- Non invasive respiratory support (NIV, High flow Nasal Therapy (HFNT)) at study inclusion
- Withdrawal of life support or palliation as the goal of care
- patients' or next of kin refusal to participate to the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, G1V4G5
Pierre-Alexandre Bouchard, 418-656-8711 ext. 2712, pierre-alexandre.bouchard@criucpq.ulaval.ca
Francois Lellouche
About this study
Official title: Automated Oxygen Titration - Monitoring and Weaning in Patients With Infectious Pneumonia Requiring Oxygen - Impact on the Number of Interventions for Healthcare Workers. An Innovative Device to Manage Patients With COVID-19 Pneumonia COVID Study (Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decreaseduring Pneumonia)
There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers.
Automated oxygen titration, weaning and monitoring (FreeO2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.
- Conditions
- Coronavirus, Pneumonia, Oxygen Toxicity
- Being tested
- Standard administration of oxygen flow, Automated oxygen administration - FreeO2
- Medical subject headings
- Coronavirus Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard administration of oxygen flowOther
The investigator recommended SpO2 target of 90-94%. The investigator will recommend that low/high SpO2 alarms be set at 88% and 96% if continuous oximetry is used.
In this group the SpO2 was recorded any time with FreeO2 device - recording mode
Automated oxygen administration - FreeO2Device
In this group, oxygen administration will be delivered with FreeO2 (automated oxygen titration) with SpO2 target set at 92% (to maintain oxygenation in the recommended SpO2 target: 90-94%)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Usual care will be provide to patients concerning their medical management.
In the Control Group usual, oxygen will be delivered as per usual local practices Receives: Other: Standard administration of oxygen flow |
| Intervention group | Experimental | Usual care will be provide to patients concerning their medical management.
In the Intervention group, automated oxygen administration will be delivered with FreeO2 Receives: Device: Automated oxygen administration - FreeO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of interventions
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Measured: Hour0 to Hour4
Duration of interventions
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Measured: Hour0 to Hour24
Secondary outcomes (11)
Mean oxygen flow
The Mean oxygen flow during study duration to evaluate oxygen consumption
Measured: Hour0 to Hour24 (1 day)
Time within theSpO2 target
Time within SpO2 between 90 and 94%
Measured: Hour0 to Hour24 (1 day)
Time with hypoxemia
Time within SpO2 < 88%
Measured: Hour0 to Hour24 (1 day)
Time with hyperoxemia
Time within SpO2 > 96%
Measured: Hour0 to Hour24 (1 day)
Rate of ICU admission
Rate of ICU admission
Measured: Hour0 to Hour24 (1 day)
Rate of needed non invasive respiratory support
Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Measured: Hour0 to Hour24 (1 day)
Rate of intubation
Rate of intubation
Measured: Hour0 to Hour24 (1 day)
NEWS 2 score evolution
Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
Measured: Hour0 to Hour24 (1 day)
EWSO2 score evolution
Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Measured: Hour0 to Hour24 (1 day)
Cost-effectiveness
Cost effectiveness ratio (cost per SpO2 unit)
Measured: From date of randomization until the date of hospital discharge
length of stay
Duration of the hospital length of stay
Measured: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start20 Apr 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Lellouche, Principal investigator, IUCPQ-UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320056
- Sponsor's protocol ID
- 21909
- Status last verified
- Apr 2020
- First submitted
- 19 Mar 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.
Publications
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Arabi YM, Balkhy HH, Hayden FG, Bouchama A, Luke T, Baillie JK, Al-Omari A, Hajeer AH, Senga M, Denison MR, Nguyen-Van-Tam JS, Shindo N, Bermingham A, Chappell JD, Van Kerkhove MD, Fowler RA. Middle East Respiratory Syndrome. N Engl J Med. 2017 Feb 9;376(6):584-594. doi: 10.1056/NEJMsr1408795.
PubMed 28177862Yu IT, Li Y, Wong TW, Tam W, Chan AT, Lee JH, Leung DY, Ho T. Evidence of airborne transmission of the severe acute respiratory syndrome virus. N Engl J Med. 2004 Apr 22;350(17):1731-9. doi: 10.1056/NEJMoa032867.
PubMed 15102999Kutter JS, Spronken MI, Fraaij PL, Fouchier RA, Herfst S. Transmission routes of respiratory viruses among humans. Curr Opin Virol. 2018 Feb;28:142-151. doi: 10.1016/j.coviro.2018.01.001. Epub 2018 Jan 17.
PubMed 29452994Levy MM, Baylor MS, Bernard GR, Fowler R, Franks TJ, Hayden FG, Helfand R, Lapinsky SE, Martin TR, Niederman MS, Rubenfeld GD, Slutsky AS, Stewart TE, Styrt BA, Thompson BT, Harabin AL; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; Institute of Allergy and Infectious Diseases. Clinical issues and research in respiratory failure from severe acute respiratory syndrome. Am J Respir Crit Care Med. 2005 Mar 1;171(5):518-26. doi: 10.1164/rccm.200405-621WS. Epub 2004 Dec 10.
PubMed 15591472Booth CM, Matukas LM, Tomlinson GA, Rachlis AR, Rose DB, Dwosh HA, Walmsley SL, Mazzulli T, Avendano M, Derkach P, Ephtimios IE, Kitai I, Mederski BD, Shadowitz SB, Gold WL, Hawryluck LA, Rea E, Chenkin JS, Cescon DW, Poutanen SM, Detsky AS. Clinical features and short-term outcomes of 144 patients with SARS in the greater Toronto area. JAMA. 2003 Jun 4;289(21):2801-9. doi: 10.1001/jama.289.21.JOC30885. Epub 2003 May 6.
PubMed 12734147Fowler RA, Lapinsky SE, Hallett D, Detsky AS, Sibbald WJ, Slutsky AS, Stewart TE; Toronto SARS Critical Care Group. Critically ill patients with severe acute respiratory syndrome. JAMA. 2003 Jul 16;290(3):367-73. doi: 10.1001/jama.290.3.367.
PubMed 12865378Lew TW, Kwek TK, Tai D, Earnest A, Loo S, Singh K, Kwan KM, Chan Y, Yim CF, Bek SL, Kor AC, Yap WS, Chelliah YR, Lai YC, Goh SK. Acute respiratory distress syndrome in critically ill patients with severe acute respiratory syndrome. JAMA. 2003 Jul 16;290(3):374-80. doi: 10.1001/jama.290.3.374.
PubMed 12865379Khalid I, Khalid TJ, Qabajah MR, Barnard AG, Qushmaq IA. Healthcare Workers Emotions, Perceived Stressors and Coping Strategies During a MERS-CoV Outbreak. Clin Med Res. 2016 Mar;14(1):7-14. doi: 10.3121/cmr.2016.1303. Epub 2016 Feb 4.
PubMed 26847480Sandoval C, Barrera A, Ferres M, Cerda J, Retamal J, Garcia-Sastre A, Medina RA, Hirsch T. Infection in Health Personnel with High and Low Levels of Exposure in a Hospital Setting during the H1N1 2009 Influenza A Pandemic. PLoS One. 2016 Jan 22;11(1):e0147271. doi: 10.1371/journal.pone.0147271. eCollection 2016.
PubMed 26799564Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Lellouche F, L'Her E. Hyperoxemia: The Poison Is in the Dose. Am J Respir Crit Care Med. 2020 Feb 15;201(4):498. doi: 10.1164/rccm.201910-1898LE. No abstract available.
PubMed 31671280Chu DK, Kim LH, Young PJ, Zamiri N, Almenawer SA, Jaeschke R, Szczeklik W, Schunemann HJ, Neary JD, Alhazzani W. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018 Apr 28;391(10131):1693-1705. doi: 10.1016/S0140-6736(18)30479-3. Epub 2018 Apr 26.
PubMed 29726345O'Driscoll BR, Howard LS, Earis J, Mak V; British Thoracic Society Emergency Oxygen Guideline Group; BTS Emergency Oxygen Guideline Development Group. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017 Jun;72(Suppl 1):ii1-ii90. doi: 10.1136/thoraxjnl-2016-209729. No abstract available.
PubMed 28507176
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Oxygen Titration - Monitoring and Weaning in Patients With Infectious Pneumonia Requiring Oxygen - Impact on the Number of Interventions for Healthcare Workers. An Innovative Device to Manage Patients With COVID-19 Pneumonia COVID Study (Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decreaseduring Pneumonia)
- ClinicalTrials.gov ID
- NCT04320056
- Acronym / sponsor ID
- 21909
- Conditions
- Coronavirus, Pneumonia, Oxygen Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers.
Automated oxygen titration, weaning and monitoring (FreeO2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard administration of oxygen flowUsual care will be provide to patients concerning their medical management. In the Control Group usual, oxygen will be delivered as per usual local practices |
| Intervention group | Experimental | Device: Automated oxygen administration - FreeO2Usual care will be provide to patients concerning their medical management. In the Intervention group, automated oxygen administration will be delivered with FreeO2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18 years old
- patients with acute respiratory failure related to suspected community acquired pneumonia (viral and non viral) requiring oxygen therapy < 6 L/min (or FiO2< 0.50) (to maintain SpO2 between 90 and 94% SpO2) without criteria for immediate intubation or ICU transfer.
- Patients hospital admission < 72 hours
Key exclusion criteria (8 listed)
- shock state,
- no SpO2 signal available,
- patient agitation,
- pH < 7.30 (if blood gas available)
- PaCO2 > 50 mmHg, (if blood gas available) or chronic hypercapnia history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard administration of oxygen flowThe investigator recommended SpO2 target of 90-94%. The investigator will recommend that low/high SpO2 alarms be set at 88% and 96% if continuous oximetry is used. In this group the SpO2 was recorded any time with FreeO2 device - recording mode | Other | Control group |
| Automated oxygen administration - FreeO2In this group, oxygen administration will be delivered with FreeO2 (automated oxygen titration) with SpO2 target set at 92% (to maintain oxygenation in the recommended SpO2 target: 90-94%) | Device | Intervention group |
Primary outcome
The number of interventions
Time frame: Hour0 to Hour4
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Duration of interventions
Time frame: Hour0 to Hour24
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
11 secondary outcomes
Mean oxygen flow
Time frame: Hour0 to Hour24 (1 day)
Time within theSpO2 target
Time frame: Hour0 to Hour24 (1 day)
Time with hypoxemia
Time frame: Hour0 to Hour24 (1 day)
Time with hyperoxemia
Time frame: Hour0 to Hour24 (1 day)
Rate of ICU admission
Time frame: Hour0 to Hour24 (1 day)
Rate of needed non invasive respiratory support
Time frame: Hour0 to Hour24 (1 day)
Rate of intubation
Time frame: Hour0 to Hour24 (1 day)
NEWS 2 score evolution
Time frame: Hour0 to Hour24 (1 day)
EWSO2 score evolution
Time frame: Hour0 to Hour24 (1 day)
Cost-effectiveness
Time frame: From date of randomization until the date of hospital discharge
length of stay
Time frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 28177862Arabi YM, Balkhy HH, Hayden FG, Bouchama A, Luke T, Baillie JK, Al-Omari A, Hajeer AH, Senga M, Denison MR, Nguyen-Van-Tam JS, Shindo N, Bermingham A, Chappell JD, Van Kerkhove MD, Fowler RA. Middle East Respiratory Syndrome. N Engl J Med. 2017 Feb 9;376(6):584-594. doi: 10.1056/NEJMsr1408795.
- Background: PubMed 15102999Yu IT, Li Y, Wong TW, Tam W, Chan AT, Lee JH, Leung DY, Ho T. Evidence of airborne transmission of the severe acute respiratory syndrome virus. N Engl J Med. 2004 Apr 22;350(17):1731-9. doi: 10.1056/NEJMoa032867.
- Background: PubMed 29452994Kutter JS, Spronken MI, Fraaij PL, Fouchier RA, Herfst S. Transmission routes of respiratory viruses among humans. Curr Opin Virol. 2018 Feb;28:142-151. doi: 10.1016/j.coviro.2018.01.001. Epub 2018 Jan 17.
- Background: PubMed 15591472Levy MM, Baylor MS, Bernard GR, Fowler R, Franks TJ, Hayden FG, Helfand R, Lapinsky SE, Martin TR, Niederman MS, Rubenfeld GD, Slutsky AS, Stewart TE, Styrt BA, Thompson BT, Harabin AL; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; Institute of Allergy and Infectious Diseases. Clinical issues and research in respiratory failure from severe acute respiratory syndrome. Am J Respir Crit Care Med. 2005 Mar 1;171(5):518-26. doi: 10.1164/rccm.200405-621WS. Epub 2004 Dec 10.
- Background: PubMed 12734147Booth CM, Matukas LM, Tomlinson GA, Rachlis AR, Rose DB, Dwosh HA, Walmsley SL, Mazzulli T, Avendano M, Derkach P, Ephtimios IE, Kitai I, Mederski BD, Shadowitz SB, Gold WL, Hawryluck LA, Rea E, Chenkin JS, Cescon DW, Poutanen SM, Detsky AS. Clinical features and short-term outcomes of 144 patients with SARS in the greater Toronto area. JAMA. 2003 Jun 4;289(21):2801-9. doi: 10.1001/jama.289.21.JOC30885. Epub 2003 May 6.
- Background: PubMed 12865378Fowler RA, Lapinsky SE, Hallett D, Detsky AS, Sibbald WJ, Slutsky AS, Stewart TE; Toronto SARS Critical Care Group. Critically ill patients with severe acute respiratory syndrome. JAMA. 2003 Jul 16;290(3):367-73. doi: 10.1001/jama.290.3.367.
- Background: PubMed 12865379Lew TW, Kwek TK, Tai D, Earnest A, Loo S, Singh K, Kwan KM, Chan Y, Yim CF, Bek SL, Kor AC, Yap WS, Chelliah YR, Lai YC, Goh SK. Acute respiratory distress syndrome in critically ill patients with severe acute respiratory syndrome. JAMA. 2003 Jul 16;290(3):374-80. doi: 10.1001/jama.290.3.374.
- Background: PubMed 26847480Khalid I, Khalid TJ, Qabajah MR, Barnard AG, Qushmaq IA. Healthcare Workers Emotions, Perceived Stressors and Coping Strategies During a MERS-CoV Outbreak. Clin Med Res. 2016 Mar;14(1):7-14. doi: 10.3121/cmr.2016.1303. Epub 2016 Feb 4.
- Background: PubMed 26799564Sandoval C, Barrera A, Ferres M, Cerda J, Retamal J, Garcia-Sastre A, Medina RA, Hirsch T. Infection in Health Personnel with High and Low Levels of Exposure in a Hospital Setting during the H1N1 2009 Influenza A Pandemic. PLoS One. 2016 Jan 22;11(1):e0147271. doi: 10.1371/journal.pone.0147271. eCollection 2016.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Lellouche principal investigator
IUCPQ-UL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard administration of oxygen flow and Automated oxygen administration - FreeO2 in people with Coronavirus and Pneumonia, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Lellouche (418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of interventions (time frame: Hour0 to Hour4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320056, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.