Acute Exacerbation of COPDRELEASENCT04147104
ecco2R to facilitatE earLy libEration From mechanicAl Ventilation inpatientS With Copd Acute Exacerbation
A study testing Low flow ECCO2R and Invasive mechanical ventilation in people with Acute Exacerbation of COPD, run by Hospital Quiron Sagrado Corazon.
Trial summary
A pragmatic randomised controlled trial to determine whether early Veno-Venous Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) in mechanically ventilated patients with acute exacerbated Chronic Obstructive Pulmonary Disease decreases the days of invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Low flow ECCO2R and Invasive mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Jun 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
- Age ≥ 18
- Known or suspected aeCOPD that failed NIV that requires invasive mechanical ventilation
- Failed treatment with NIV defined as:
- NIV for at least 2 hours and no more than 24 hours with signs of respiratory distress (respiratory rate > 30 breaths/min and use of accessory muscles or paradoxical abdominal movements) AND
- PaCO2> 55 mmHg and pH < 7.25 or pH < 7.30 and PaCO2 > 55 mmHg, with PaCO2 decrease < 20% from baseline
- Known or suspected aeCOPD patients where NIV is contraindicated and need immediate invasive mechanical ventilation due to:
Show all 12Show fewer
- Respiratory arrest
- Inability to protect the airway (impaired cough or swallowing or massive aspiration or respiratory pauses with loss of consciousness or gasping of air)
- Inability to clear secretions
- Agitated and confused patients
- Facial deformities or conditions that prevent mask from fitting
- Uncooperative or unmotivated patients
Who cannot join
- Participation in other interventional studies
- Patients already included in this study that need a new readmission because of a new aeCOPD episode
- aeCOPD intubated > 12 hours
- Extubation within the previous 48 hours following intubation and invasive mechanical ventilation due to any cause
- Anatomical abnormalities or vascular diseases preventing the correct insertion of the ECCO2R cannula
- PaO2 to FiO2 ratio < 150 on PEEP ≥ 5 cmH2O
Show all 43Show fewer
- Known or suspected pregnancy (women of childbearing potential require a pregnancy test)
- Hemodynamic instability defined as
- MAP < 60 mmHg despite the infusion of fluids or vasoactive drugs OR
- Failure to increase systolic blood pressure above 80-90 mmHg OR
- Need for inotropic drugs to maintain systolic blood pressure> 85 mmHg OR
- ECG evidence of ischemia or significant uncontrolled ventricular arrhythmia
- Acute multiple organ failure defined as more than two organ failures assessed by SOFA score. Organ dysfunction can be identified as an acute change in total SOFA score > 2 points
- Decompensated heart failure defined as an exacerbation of symptoms or signs after a period of relative stability such as dyspnea, fatigue or edema in the setting of previously established myocardial dysfunction (systolic or diastolic)32 and B-natriuretic peptide more than100 ng/L.
- Tracheostomized patients
- Untreated pulmonary embolism, pleural effusion, pneumothorax or bronchopleural fistula as the primary cause of acute respiratory failure
- Hemoglobin < 7 gr/dL that require daily transfusion to maintain hemoglobin above 7 gr/dL at the time of screening
- Active major bleeding defined as35:
- Fatal bleeding
- Bleeding that is symptomatic and occurs in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, in a non-operated joint, or intramuscular with compartment syndrome, assessed in consultation with the MD
- Extrasurgical site bleeding causing a fall in hemoglobin level of 2 gr/dL or more or leading to transfusion of two or more units of whole blood or red cells, with temporal association within 24-48 hours to the bleeding
- Recent major surgery in the last 2 weeks
- Platelet count < 50 000/mm3
- Prothrombin time-international normalized ratio (INR) > 1.5 in the absence of anticoagulation therapy
- Heparin-induced thrombocytopenia (HIT) or known paradoxical/allergic reactions to heparin
- History within the previous 3 months of stroke or severe head trauma or intracranial arterio-venous malformation, or cerebral aneurysm, or central nervous mass lesion or intracranial bleeding
- Epidural catheter in place or plan to insert an epidural catheter during the study
- Gastrointestinal bleeding within the 6 weeks prior to study entry
- Severe liver insufficiency (Child-Pugh scores >7) or INR > 1.6 suspected to be related to liver disease (liver associated coagulopathy)
- Presence of severe (acute or chronic) renal failure defined as requiring any form of dialysis (including CRRT and CVVH) and/or having a serum creatinine > 2.5 mg/dL and urine clearance < 20 mL/hour
- Inability to receive blood products
- History of complications from extracorporeal support
- Permanent home ventilation except for sleep-disordered breathing
- Significant weakness or paralysis of respiratory muscles due to causes unrelated to aeCOPD
- Recent (< 7 days) prolonged (> 24 hours) use of muscle paralyzing agents
- Immunocompromised state defined as
- Received chemotherapy or radiation within the previous 45 days and still under treatment for the underlying cancer
- Received or currently receiving immunosuppressive therapy, excluding corticosteroids, within the last 3 months
- Known to have AIDS defined illness
- Patients not expected to survive 6 months on the basis of premorbid health status
- History of uncontrolled, major psychiatric disorder
- Therapeutic restriction (DNR), moribund patient or not expected to survive current hospitalization
- Consent declined
Trial locations and contacts
No sites are listed yet.
About this study
A pragmatic randomised controlled trial to determine whether early Veno-Venous Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) in mechanically ventilated patients with acute exacerbated Chronic Obstructive Pulmonary Disease decreases the days of invasive mechanical ventilation.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major worldwide health burden. Currently, it is the fourth leading cause of death worldwide, and is the only leading cause of death that is rising, and will likely become the third cause of death by 2020. COPD is characterized by progressive destruction in the elastic tissue within the lung, causing respiratory failure.
Patients with COPD may experience acute exacerbations with severe hypercapnic respiratory failure. Hypercapnia results from acute worsening of expiratory flow limitation caused by the increased small airway resistance with consequent development of dynamic alveolar hyperinflation and intrinsic positive end-expiratory pressure (PEEP). In the most severe cases, these may be refractory to conventional therapies and mechanical ventilation, becoming life-threatening.
Extracorporeal carbon dioxide removal (ECCO2R) represents an attractive approach in this setting. The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure, as demonstrated by the progressively increasing number of scientific publications on this topic. In particular, remarkable interest has been focused on extracorporeal carbon dioxide removal (ECCO2R), due to the relative ease and efficiency in blood CO2 clearance granted by extracorporeal gas exchangers as compared to oxygen delivery.
In recent years, a new generation of ECCO2R devices has been developed. More efficient veno-venous (VV)-ECCO2R devices have become available and have replaced the arterio-venous approach, having the advantage of not requiring arterial puncture.
The new VV-ECCO2R devices offer lower resistance to blood flow, have smaller priming volumes, and provide a much more efficient gas exchange with relatively low extracorporeal blood flows (0.4-1 L/min). The technology of these devices is now comparable to that of renal dialysis and has been experimented in several animal and human studies, demonstrating a significant reduction in arterial CO2 and improvement in the work of breathing.
In summary, minimally invasive ECCO2R appears very promising for patients with acute exacerbation of obstructive diseases refractory to conventional treatment, but systematic evaluation is needed to prove its clinical efficacy.
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Low flow ECCO2R, Invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow ECCO2RDevice
Treatment with a medical device called ECCO2R. The device consists of a drainage cannula placed in a large central vein, a membrane lung (artificial gas exchanger), and a return cannula into the venous system. Blood is pumped through the membrane lung, and CO2 is removed by diffusion. A flowing gas known as "sweep gas" containing little or no CO2 runs along the other side of the membrane, ensuring a diffusion gradient from blood to the other side, hence promoting CO2 removal.
Invasive mechanical ventilationDevice
Invasive mechanical ventilation deviceto support acute respiratory failure and facilitate exhalation via an endotracheal tube or tracheotomy.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care plus invasive mechanical ventilation | Active comparator | Invasive mechanical ventilation for lung support and to facilitate exhalation via an endotracheal tube o tracheotomy. Receives: Device: Invasive mechanical ventilation |
| ECCO2R plus invasive mechanical ventilation | Experimental | Low-flow ECCO2R adjunct to standard-of-care and invasive mechanical ventilation. Receives: Device: Low flow ECCO2R; Device: Invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of time in the first 28 days following randomization that a patient is free of ventilatory support including non-invasive ventilation
Statistically analyzed as Ventilator-Free Days during the 28 days from randomization (VFD-28)
Measured: 28 days
Secondary outcomes (15)
All-cause (health-related) mortality at 28 and 90 days from randomization
Incidence of health-related deaths at 28 and 90 days from randomization, regardless of subject location at time of death.
Measured: 28 and 90 days
Health-related quality of life (HRQoL)
EQ-5D-5L is a generic preference-based measure of health, which provides a description of health using five dimensions (mobility, self-care, usual activities, pain/discomfort and anxie-ty/depression) each with 5 levels of severity.
Measured: 90 days after randomization
Catheter-related complications
Bleeding, malposition, dislodgement or kinking, infection, vascular occlusion, thrombosis, hematoma, aneurism, pseudoaneurysm formation
Measured: Participants will be followed for the duration of ICU stay, an expected average of 30 days
Work of breathing
Assessed by respiratory rate (cutoff 30 breaths/min) and use of accessory muscles or paradoxical abdominal movements
Measured: Participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to ECCO2R cessation
Defined as from the onset of ECCO2R to 6 hours following cessation of CO2 removal
Measured: Participants will be followed for the duration of ICU stay, an expected average of 4 days
Length of ECCO2R in situ
Defined as the insertion of cannulas until there removal
Measured: 7 days
Time to normalization of pH and PaCO2
Measured: 3 hours
Length of ICU stay
Participants will be followed for the duration of ICU stay
Measured: 4 days
Hospital Length of stay
Participants will be followed for the duration of hospital stay
Measured: 10 days
Incidence of new tracheostomies
Incidence of new tracheostomies
Measured: Within 28 days from randomization
Tolerance of ECCO2R therapy
Assessed by comfort, defined according a visual analog comfort scale (VAS). The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).
Measured: 4 days
Dyspnea
Assessed by the modified Borg scale. This is a scale rates the difficulty of breathing. It starts at number 0 where dyspnea is causing no difficulty at all and progresses through to number 10 where dyspnea is maximal.
Measured: 4 days
ICU Mobility
Ability of subject to mobilize in bed and out of bed while in Intensive Care as assessed using ICU Mobility Score (IMS)
Measured: Randomization to end of treatment or 14 days, whichever is sooner
Incidence of failed extubations
Incidence of re-intubation within 48 hours of extubation for original exacerbation
Measured: Within 28 days from randomization
Frailty Index Score
The Clinical Frailty Scale is scored on a scale from 1 (very fit) to 9 (terminally ill) and is based on clinical judgment.
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study startFeb 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Quiron Sagrado Corazon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Morales, Hospital Quiron Sagrado Corazon
- Investigators
- Antonio Artigas, MD, Principal investigator, Hospital Universitari Sagrat Cor, Grupo Quironsalud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147104
- Sponsor's protocol ID
- 2019/53-UCI-HUSC
- Acronym
- RELEASE
- Status last verified
- Aug 2020
- First submitted
- 27 Oct 2019
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607.
PubMed 25230375Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.
PubMed 23460154
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ecco2R to facilitatE earLy libEration From mechanicAl Ventilation inpatientS With Copd Acute Exacerbation
- ClinicalTrials.gov ID
- NCT04147104
- Acronym / sponsor ID
- RELEASE / 2019/53-UCI-HUSC
- Conditions
- Acute Exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Quiron Sagrado CorazonUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 31 Oct 2019 (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.
A pragmatic randomised controlled trial to determine whether early Veno-Venous Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) in mechanically ventilated patients with acute exacerbated Chronic Obstructive Pulmonary Disease decreases the days of invasive mechanical ventilation.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major worldwide health burden. Currently, it is the fourth leading cause of death worldwide, and is the only leading cause of death that is rising, and will likely become the third cause of death by 2020. COPD is characterized by progressive destruction in the elastic tissue within the lung, causing respiratory failure.
Patients with COPD may experience acute exacerbations with severe hypercapnic respiratory failure. Hypercapnia results from acute worsening of expiratory flow limitation caused by the increased small airway resistance with consequent development of dynamic alveolar hyperinflation and intrinsic positive end-expiratory pressure (PEEP). In the most severe cases, these may be refractory to conventional therapies and mechanical ventilation, becoming life-threatening.
Extracorporeal carbon dioxide removal (ECCO2R) represents an attractive approach in this setting. The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure, as demonstrated by the progressively increasing number of scientific publications on this topic. In particular, remarkable interest has been focused on extracorporeal carbon dioxide removal (ECCO2R), due to the relative ease and efficiency in blood CO2 clearance granted by extracorporeal gas exchangers as compared to oxygen delivery.
In recent years, a new generation of ECCO2R devices has been developed. More efficient veno-venous (VV)-ECCO2R devices have become available and have replaced the arterio-venous approach, having the advantage of not requiring arterial puncture.
The new VV-ECCO2R devices offer lower resistance to blood flow, have smaller priming volumes, and provide a much more efficient gas exchange with relatively low extracorporeal blood flows (0.4-1 L/min). The technology of these devices is now comparable to that of renal dialysis and has been experimented in several animal and human studies, demonstrating a significant reduction in arterial CO2 and improvement in the work of breathing.
In summary, minimally invasive ECCO2R appears very promising for patients with acute exacerbation of obstructive diseases refractory to conventional treatment, but systematic evaluation is needed to prove its clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care plus invasive mechanical ventilation | Active comparator | Device: Invasive mechanical ventilationInvasive mechanical ventilation for lung support and to facilitate exhalation via an endotracheal tube o tracheotomy. |
| ECCO2R plus invasive mechanical ventilation | Experimental | Device: Low flow ECCO2R, Device: Invasive mechanical ventilationLow-flow ECCO2R adjunct to standard-of-care and invasive mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- NIV for at least 2 hours and no more than 24 hours with signs of respiratory distress (respiratory rate > 30 breaths/min and use of accessory muscles or paradoxical abdominal movements) AND
- PaCO2> 55 mmHg and pH < 7.25 or pH < 7.30 and PaCO2 > 55 mmHg, with PaCO2 decrease < 20% from baseline
- Respiratory arrest
- Inability to protect the airway (impaired cough or swallowing or massive aspiration or respiratory pauses with loss of consciousness or gasping of air)
- Inability to clear secretions
Key exclusion criteria (43 listed)
- Participation in other interventional studies
- Patients already included in this study that need a new readmission because of a new aeCOPD episode
- aeCOPD intubated > 12 hours
- Extubation within the previous 48 hours following intubation and invasive mechanical ventilation due to any cause
- Anatomical abnormalities or vascular diseases preventing the correct insertion of the ECCO2R cannula
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 |
|---|---|---|
| Low flow ECCO2RTreatment with a medical device called ECCO2R. The device consists of a drainage cannula placed in a large central vein, a membrane lung (artificial gas exchanger), and a return cannula into the venous system. Blood is pumped through the membrane lung, and CO2 is removed by diffusion. A flowing gas known as "sweep gas" containing little or no CO2 runs along the other side of the membrane, ensuring a diffusion gradient from blood to the other side, hence promoting CO2 removal. | Device | ECCO2R plus invasive mechanical ventilation |
| Invasive mechanical ventilationInvasive mechanical ventilation deviceto support acute respiratory failure and facilitate exhalation via an endotracheal tube or tracheotomy. | Device | ECCO2R plus invasive mechanical ventilation, Standard-of-care plus invasive mechanical ventilation |
Primary outcome
The amount of time in the first 28 days following randomization that a patient is free of ventilatory support including non-invasive ventilation
Time frame: 28 days
Statistically analyzed as Ventilator-Free Days during the 28 days from randomization (VFD-28)
15 secondary outcomes
All-cause (health-related) mortality at 28 and 90 days from randomization
Time frame: 28 and 90 days
Health-related quality of life (HRQoL)
Time frame: 90 days after randomization
Catheter-related complications
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 30 days
Work of breathing
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to ECCO2R cessation
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 4 days
Length of ECCO2R in situ
Time frame: 7 days
Time to normalization of pH and PaCO2
Time frame: 3 hours
Length of ICU stay
Time frame: 4 days
Hospital Length of stay
Time frame: 10 days
Incidence of new tracheostomies
Time frame: Within 28 days from randomization
Tolerance of ECCO2R therapy
Time frame: 4 days
Dyspnea
Time frame: 4 days
ICU Mobility
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
Incidence of failed extubations
Time frame: Within 28 days from randomization
Frailty Index Score
Time frame: 90 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Background: PubMed 25230375Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607.
- Background: PubMed 23460154Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Antonio Artigas, MD principal investigator
Hospital Universitari Sagrat Cor, Grupo Quironsalud
Questions about this trial
What is this clinical trial studying?
A study testing Low flow ECCO2R and Invasive mechanical ventilation in people with Acute Exacerbation of COPD, run by Hospital Quiron Sagrado Corazon.
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 12 inclusion and 43 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 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Luis Morales, MD (+ 34 648493973, luchomq2077@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of time in the first 28 days following randomization that a patient is free of ventilatory support including non-invasive ventilation (time frame: 28 days). 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 NCT04147104, which also lists 2 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 20 Aug 2020.