Acute Respiratory Distress Syndrome (ARDS)Phase 3LidoCovidNCT04609865
Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
A Phase 3 study testing Lidocaine 2% in people with Acute Respiratory Distress Syndrome (ARDS) and COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), COVID-19, Corona Virus Infection
- What is being tested?
- Lidocaine 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2020to 17 Mar 2022
- Phase
- Phase 3
- 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
- Hospitalized in ICU
- Presence of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms:
- PaO2/FiO2 <300 mmHg with positive end-expiratory pressure (PEEP) ≥5 cmH2O
- Bilateral opacities not fully explained by cardiac failure or fluid overload
- Intubated and sedated for mechanical protective ventilation
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- Affiliation to the French Sociale security
- Beta HCG negative for women
- For Covid-19 subgroup:
- Covid-19 infection (RT-PCR < 7 days and/or another approved diagnostic technique and/or typical CT appearance of COVID-19 pneumonia
Who cannot join
- Allergy to amide local anesthetics
- Acute porphyria
- Disorders of atrioventricular conduction requiring a non-done permanent electrosystolic pacing
- Uncontrolled epilepsy
- Fluvoxamine treatment
- Class III antiarrythmic agent treatments (amiodarone, dronedarone)
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- Class I antiarythmic agent (quinidine, disopyramide, hydroquinidine, flecainid, propafenone)
- Hepatocellular insufficiency defined by PT<15% in the absence of anti-vitamin K
- Patient under a tutelage measure or placed under judicial protection
- Known pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia.
Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.
- Being tested
- Lidocaine 2%, Control
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2%Drug
the lidocaine infusion protocol is a bolus of 1 mg/kg (ideal weight), followed by 3mg/kg/h for the first hour, 1.5 mg/kg/h for the second hour, 0.72 mg/kg/h for the next 22 hours, and then 0.6mg/kg/h for 14 days or until extubation.
ControlDrug
The NaCl 0,9% infusion protocol is a bolus of 0.05 ml/kg (ideal weight), followed by 0.15 ml/kg/h for the first hour, 0.075 ml/kg/h for the second hour, 0.36 ml/kg/h for the next 22 hours, and then 0.03 ml/kg/h for 14 days or until extubation.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 2% | Experimental | The lidocaine infusion protocol is a bolus of 1 mg/kg (ideal weight), followed by 3mg/kg/h for the first hour, 1.5 mg/kg/h for the second hour, 0.72 mg/kg/h for the next 22 hours,and then 0.6mg/kg/h for 14 days or until extubation. Receives: Drug: Lidocaine 2% |
| Control | Placebo comparator | The NaCl 0,9% infusion protocol is a bolus of 0.05 ml/kg (ideal weight), followed by 0.15 ml/kg/h for the first hour, 0.075 ml/kg/h for the second hour, 0.36 ml/kg/h for the next 22 hours, and then 0.03 ml/kg/h for 14 days or until extubation. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar-capillary gas exchange after two days of treatment
PaO2/FiO2 ratio
Measured: At 48 hours after the first treatment administration
Secondary outcomes (28)
alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care
PaO2/FiO2 ratio : a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: From day 0 to day 21 or until coming out of intensive care
Ventilator-free days
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At day 28 and at day 90
Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : CRP
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : LDH
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on platelets
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on ACT ratio
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on fibrinogen
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on D-Dimers
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on TEG
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on thromboembolic events
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: At Day 0, day 2, day 7, day 14 and at day 21
Plasma concentration of albumin and Lidocaine
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: 4 hours after first administration, at day 2, day 7, day 14 and at day 21
Search for hemodynamic dysfynction: Blood pressure measurement in mmHg
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Blood pressure in mmHg will be measured
Measured: daily from day one to day 14
Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Cardiac frequency in beats per minute will be assessed
Measured: daily from day one to day 14
Search for hemodynamic dysfynction: Sinus rythm will be assessed
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Sinus rythm will be assessed
Measured: daily from day one to day 14
Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Vasopressors and inotropes drugs use will be reported
Measured: daily from day one to day 14
Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
EKG : PR, QRS, QTc intervals in ms will be measured
Measured: daily from day one to day 14
ICU ileus: laxation response
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: daily from Day 0 to Day 28
Opioids, sedative and curare sparing effect (drugs dosage)
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: daily from Day 0 to Day 28
Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: From Day0 to Day28 and at Day90
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: From Day0 to Day28 and at Day90
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: From Day0 to Day28 and at Day90
Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)
a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measured: extubation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start4 Nov 2020
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Why it stopped: departure of the principal investigator and inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609865
- Sponsor's protocol ID
- 7820
- Acronym
- LidoCovid
- Status last verified
- May 2024
- First submitted
- 23 Oct 2020
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller M, Lefebvre F, Harlay ML, Glady L, Becker G, Muller C, Aberkane O, Tawk M, Julians M, Romoli A, Hecketsweiler S, Schneider F, Pottecher J, Chamaraux-Tran TN. Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 11;22(1):131. doi: 10.1186/s13063-021-05095-x.
PubMed 33573681
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
- ClinicalTrials.gov ID
- NCT04609865
- Acronym / sponsor ID
- LidoCovid / 7820
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of the principal investigator and inclusion difficulties
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 30 Oct 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.
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia.
Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 2% | Experimental | Drug: Lidocaine 2%The lidocaine infusion protocol is a bolus of 1 mg/kg (ideal weight), followed by 3mg/kg/h for the first hour, 1.5 mg/kg/h for the second hour, 0.72 mg/kg/h for the next 22 hours,and then 0.6mg/kg/h for 14 days or until extubation. |
| Control | Placebo comparator | Drug: ControlThe NaCl 0,9% infusion protocol is a bolus of 0.05 ml/kg (ideal weight), followed by 0.15 ml/kg/h for the first hour, 0.075 ml/kg/h for the second hour, 0.36 ml/kg/h for the next 22 hours, and then 0.03 ml/kg/h for 14 days or until extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Hospitalized in ICU
- Presence of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms:
- PaO2/FiO2 <300 mmHg with positive end-expiratory pressure (PEEP) ≥5 cmH2O
- Bilateral opacities not fully explained by cardiac failure or fluid overload
Key exclusion criteria (11 listed)
- Allergy to amide local anesthetics
- Acute porphyria
- Disorders of atrioventricular conduction requiring a non-done permanent electrosystolic pacing
- Uncontrolled epilepsy
- Fluvoxamine treatment
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 |
|---|---|---|
| Lidocaine 2%the lidocaine infusion protocol is a bolus of 1 mg/kg (ideal weight), followed by 3mg/kg/h for the first hour, 1.5 mg/kg/h for the second hour, 0.72 mg/kg/h for the next 22 hours, and then 0.6mg/kg/h for 14 days or until extubation. | Drug | Lidocaine 2% |
| ControlThe NaCl 0,9% infusion protocol is a bolus of 0.05 ml/kg (ideal weight), followed by 0.15 ml/kg/h for the first hour, 0.075 ml/kg/h for the second hour, 0.36 ml/kg/h for the next 22 hours, and then 0.03 ml/kg/h for 14 days or until extubation. | Drug | Control |
Primary outcome
alveolar-capillary gas exchange after two days of treatment
Time frame: At 48 hours after the first treatment administration
PaO2/FiO2 ratio
28 secondary outcomes
alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care
Time frame: From day 0 to day 21 or until coming out of intensive care
Ventilator-free days
Time frame: At day 28 and at day 90
Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : CRP
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : LDH
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on platelets
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on ACT ratio
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on fibrinogen
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on D-Dimers
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on TEG
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Antithrombotic activity of Intravenous Lidocaine on thromboembolic events
Time frame: At Day 0, day 2, day 7, day 14 and at day 21
Plasma concentration of albumin and Lidocaine
Time frame: 4 hours after first administration, at day 2, day 7, day 14 and at day 21
Search for hemodynamic dysfynction: Blood pressure measurement in mmHg
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: Sinus rythm will be assessed
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported
Time frame: daily from day one to day 14
Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured
Time frame: daily from day one to day 14
ICU ileus: laxation response
Time frame: daily from Day 0 to Day 28
Opioids, sedative and curare sparing effect (drugs dosage)
Time frame: daily from Day 0 to Day 28
Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation
Time frame: From Day0 to Day28 and at Day90
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay
Time frame: From Day0 to Day28 and at Day90
Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications
Time frame: From Day0 to Day28 and at Day90
Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)
Time frame: extubation day
Results and safety
The study was stopped early (reason given: departure of the principal investigator and inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 33573681Muller M, Lefebvre F, Harlay ML, Glady L, Becker G, Muller C, Aberkane O, Tawk M, Julians M, Romoli A, Hecketsweiler S, Schneider F, Pottecher J, Chamaraux-Tran TN. Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 11;22(1):131. doi: 10.1186/s13063-021-05095-x.
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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 Phase 3 study testing Lidocaine 2% in people with Acute Respiratory Distress Syndrome (ARDS) and COVID-19, run by University Hospital, Strasbourg, France 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: departure of the principal investigator and inclusion difficulties). Results are not available in the source record.
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?
alveolar-capillary gas exchange after two days of treatment (time frame: At 48 hours after the first treatment administration). 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 NCT04609865, which also lists 1 linked publication.
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 30 May 2024.