Respiratory InsufficiencyCOVAQNCT05392062
Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.
A study testing Pathophysiology of gas exchange in people with Respiratory Insufficiency, run by CHU de Reims at 1 site in France.
Trial summary
The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Pathophysiology of gas exchange
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2021to 15 Apr 2023
- 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
- Patients with a COVID-19 confirmed infection.
- Admission in intensive care unit for an acute respiratory failure requiring oxygen flow above 6l/min by facial mask.
- Presence of an arterial catheter for blood sampling.
Who cannot join
- Patients on mechanical ventilation on admission to the ICU.
- Patients requiring immediate intubation on admission.
- Patients admitted to the ICU for more than 48 hours at the time of inclusion.
- Pulmonary embolism diagnosed before admission to the ICU.
- Minor patients
- Pregnant women
- Patients under curatorship or guardianship
- Persons deprived of liberty by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.
- Conditions
- Respiratory Insufficiency
- Being tested
- Pathophysiology of gas exchange
- Keywords
- Gas exchange, COVID-19, acute respiratory distress syndrome, spontaneous breathing, Respiratory failure
- Medical subject headings
- Respiratory Insufficiency, COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathophysiology of gas exchangeOther
Exploration of pathophysiology of gas exchange
| Study group | Role | What they receive |
|---|---|---|
| Respiratory insufficiency | Other | Subject with respiratory insufficiency Receives: Other: Pathophysiology of gas exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation.
From date of admission in intensive care unit (ICU) until the date of death or disharge from ICU, assessed up to 90 days
Measured: Lenght of hospital stay in intensive care unit
Secondary outcomes (3)
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.
No provided
Measured: Day 90
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.
No provided
Measured: Day 28
Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.
No provided
Measured: At admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start9 Jun 2021
- Primary completion15 Jan 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392062
- Sponsor's protocol ID
- PO21075
- Acronym
- COVAQ
- Status last verified
- Dec 2024
- First submitted
- 9 Aug 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.
- ClinicalTrials.gov ID
- NCT05392062
- Acronym / sponsor ID
- COVAQ / PO21075
- Conditions
- Respiratory Insufficiency
- Keywords
- Gas exchange, COVID-19, acute respiratory distress syndrome, spontaneous breathing, Respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 26 May 2022 (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.
The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory insufficiency | Other | Other: Pathophysiology of gas exchangeSubject with respiratory insufficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a COVID-19 confirmed infection.
- Admission in intensive care unit for an acute respiratory failure requiring oxygen flow above 6l/min by facial mask.
- Presence of an arterial catheter for blood sampling.
Key exclusion criteria (8 listed)
- Patients on mechanical ventilation on admission to the ICU.
- Patients requiring immediate intubation on admission.
- Patients admitted to the ICU for more than 48 hours at the time of inclusion.
- Pulmonary embolism diagnosed before admission to the ICU.
- Minor patients
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 |
|---|---|---|
| Pathophysiology of gas exchangeExploration of pathophysiology of gas exchange | Other | Respiratory insufficiency |
Primary outcome
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation.
Time frame: Lenght of hospital stay in intensive care unit
From date of admission in intensive care unit (ICU) until the date of death or disharge from ICU, assessed up to 90 days
3 secondary outcomes
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.
Time frame: Day 90
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.
Time frame: Day 28
Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.
Time frame: At admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathophysiology of gas exchange in people with Respiratory Insufficiency, run by CHU de Reims at 1 site in France.
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: finished, as of the sponsor's last update on 13 Dec 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation. (time frame: Lenght of hospital stay in intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.