Critically IllnessISCANCT04383730
Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
An observational study of Critically Illness and Sedation, run by University Hospital, Clermont-Ferrand at 12 sites in 5 countries.
Trial summary
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Illness, Sedation, Invasive Mechanical Ventilation
- What is being tested?
- Intravenous sedation and Inhaled sedation
- Type of treatment
- Injection or infusion
- How many people
- 203 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 26 Jun 2020to 30 Apr 2021
- Phase
- Observational
- 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
Study population: Adult patients admitted in ICUrequiring invasive mechanical ventilation and suspected or confirmed COVID19
Who may be able to join
- Adult patients (18 years old),
- Admitted to a participating ICU (or any other ICU-like setting that may be deployed as a result of the COVID-19 pandemics, such as in the operating room, post-anesthesia care unit, step-down unit or any COVID-19-specific unit set in response to the pandemics in a participating center),
- Requiring invasive mechanical ventilation,
- With suspected or confirmed COVID-19 on day 0.
Who cannot join
- None
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
France5 sites
CHU
Brest
CHU
Clermont-Ferrand, 63000
Centre Hospitalier
Dunkirk
Pitié-Salpêtrière Hospital - APHP
Paris, 75013
CH Privé de la Loire
Saint-Etienne
Germany3 sites
Universitätsklinikum
Bochum
University Medical Center Schleswig-Holstein
Kiel
Universitätsklinikum
Oldenburg
Switzerland2 sites
Cantonal Hospital
Münsterlingen
Universitätsspital
Zurich
United States1 site
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, 02215
About this study
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation.
The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to:
- assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective),
- investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective),
- report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).
Read the detailed description
The acute respiratory distress syndrome (ARDS) is the most severe and lethal complication of COVID-19, and healthcare resource utilizations are currently being heavily challenged in most countries worldwide, with a high risk that some intensive care resources, such as the number of ventilators to allow management all patients, may be insufficient to face the current surge in ARDS cases. There is, therefore, an urgent need to evaluate candidate therapies that may impact clinical outcomes in patients with COVID-19-related ARDS and potentially be relevant to current public health issues, in accordance with the international efforts by the World Health Organization (WHO) (Global research on coronavirus disease) and most international public health organizations. Beyond the current efforts to find specific antiviral therapies or vaccines, improving supportive care and treatment options for patients with COVID-19-related ARDS, in accordance with up-to-date guidelines on the management of critically ill patients with COVID-19 (Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019; The Australian and New Zealand Intensive Care Society (ANZICS) COVID-19 Guidelines; Recommandations d'experts SRLF-SFAR-SFMU-GFRUP-SPILF sur la prise en charge en réanimation des patients en période d'épidémie à SARS-CoV2), is of major importance.
Indeed, given the number of intensive care unit (ICU) patients for whom the question of sedation applies during the current COVID-19 outbreak, any sedation practice that would be associated with improved clinical outcomes could have significant economic and public health implications. In this perspective, the rationale supporting inhaled sedation with halogenated agents (such as isoflurane or sevoflurane) as a way to improve lung function, to decrease the inflammatory response, and to possibly improve patient outcome is strong.
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation. The authors, therefore, designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to :
- assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective),
- investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective),
- report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).
This study will be performed in accordance with the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement.
- Conditions
- Critically Illness, Sedation, Invasive Mechanical Ventilation, Acute Respiratory Distress Syndrome
- Being tested
- Intravenous sedation, Inhaled sedation
- Keywords
- Mechanical ventilation, Acute Respiratory Distress Syndrome, Inhaled sedation, Intravenous sedation, Covid-19
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous sedationDrug
Patients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices
Inhaled sedationDrug
Patients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices
| Study group | Role | What they receive |
|---|---|---|
| Usual practice of intravenous sedation | The choice of the intravenous sedative agent, including the type of and dosing of the agent, will be as per the treating clinicians at each center Receives: Drug: Intravenous sedation | |
| Usual practice of inhaled sedation | The choice of the inhaled sedative agent, including the type of and dosing of the agent, will be as per the treating clinicians at each center. Receives: Drug: Inhaled sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days off the ventilator (VFD28, for ventilator-free days), taking into account death as a competing event
Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 27 or died prior to day 28, VFDs will be zero. Patients transferred to another hospital or other health care facility will be followed to day 28 to assess this endpoint.
Measured: Day 28 after inclusion
Secondary outcomes (21)
All-cause mortality
All-cause mortality
Measured: Days 7, 14, and 28 after inclusion
Ventilator-free days
Ventilator-free days to days 7 and 14 are defined as the number of days from the time of initiating unassisted breathing to day 7 and 14 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to days 7 and 14 If a patient returns to assisted breathing and subsequently achieves unassisted breathing to days 7 and 14 , VFDs will be counted from the end of the last period of assisted breathing to days 7 and 14. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 6 or 13 or died prior to days 7 and 14, respectively,VFDs to days 7 and 14 will be zero. Patients transferred to another hospital or other health care facility will be followed to days 7 and 14 to assess this endpoint.
Measured: Days 7 and 14 after inclusion
ICU-free days
Number of days alive and not in the ICU from inclusion to day 28
Measured: Day 28 after inclusion
Duration of invasive mechanical ventilation
Total duration of controlled mechanical ventilation to day 28
Measured: Day 28 after inclusion
Duration of controlled mechanical ventilation
Total duration of controlled mechanical ventilation to day 28
Measured: Day 28 after inclusion
Physiological measures of lung function
Arterial hypoxemia, as assessed by the partial pressure of arterial oxygen-to-fraction of inspired oxygen ratio (PaO2/FiO2)
Measured: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Partial pressure of arterial carbon dioxide (PaCO2)
Measured: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Inspiratory plateau pressure
Measured: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Driving pressure
Measured: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Mode of mechanical ventilation (assisted versus controlled)
Measured: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
If available, 100 ms occlusion pressure (P0.1), a marker of respiratory drive
Measured: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Development of complications
Development of pneumothorax
Measured: Day 7 from inclusion
Development of complications
Supraventricular tachycardia
Measured: Day 7 from inclusion
Development of complications
New onset atrial fibrillation
Measured: Day 7 from inclusion
Duration of vasopressor use
Total duration (in days) of vasopressor use
Measured: Day 28 after inclusion
Duration of renal replacement therapy
Total duration (in days)of renal replacement therapy
Measured: Day 28 after inclusion
Duration (in days) of any adjuvant therapies
Adjuvant therapies are defined as: prone position, recruitment maneuvers, inhaled nitric oxide, inhaled epoprostenol sodium, high frequency ventilation, ECMO, neuromuscular blockade
Measured: Day 7 from inclusion
Duration of continuous neuromuscular blockade
Number of days with continuous neuromuscular blockade
Measured: Day 28 from inclusion
Type of sedation practices
Sedation drug(s) used (name(s))
Measured: Day 28 from inclusion
Duration of sedation practices
Number of days with sedation
Measured: Day 28 from inclusion
Modalities of sedation practices
If inhaled sedation, device used to deliver it
Measured: Day 28 from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start26 Jun 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 Critically IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia, University Hospital Schleswig-Holstein, Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
- Investigators
- Matthieu Jabaudon, Study chair, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383730
- Sponsor's protocol ID
- ISCA Study
- Acronym
- ISCA
- Status last verified
- Aug 2021
- First submitted
- 8 May 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blondonnet R, Quinson A, Lambert C, Audard J, Godet T, Zhai R, Pereira B, Futier E, Bazin JE, Constantin JM, Jabaudon M. Use of volatile agents for sedation in the intensive care unit: A national survey in France. PLoS One. 2021 Apr 15;16(4):e0249889. doi: 10.1371/journal.pone.0249889. eCollection 2021.
PubMed 33857185
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
- ClinicalTrials.gov ID
- NCT04383730
- Acronym / sponsor ID
- ISCA / ISCA Study
- Conditions
- Critically Illness, Sedation, Invasive Mechanical Ventilation, Acute Respiratory Distress Syndrome
- Keywords
- Mechanical ventilation, Acute Respiratory Distress Syndrome, Inhaled sedation, Intravenous sedation, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia, University Hospital Schleswig-Holstein, Groupe Hospitalier Pitie-Salpetriere
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 12 May 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 authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation.
The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to:
- assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective),
- investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective),
- report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).
Detailed description
The acute respiratory distress syndrome (ARDS) is the most severe and lethal complication of COVID-19, and healthcare resource utilizations are currently being heavily challenged in most countries worldwide, with a high risk that some intensive care resources, such as the number of ventilators to allow management all patients, may be insufficient to face the current surge in ARDS cases. There is, therefore, an urgent need to evaluate candidate therapies that may impact clinical outcomes in patients with COVID-19-related ARDS and potentially be relevant to current public health issues, in accordance with the international efforts by the World Health Organization (WHO) (Global research on coronavirus disease) and most international public health organizations. Beyond the current efforts to find specific antiviral therapies or vaccines, improving supportive care and treatment options for patients with COVID-19-related ARDS, in accordance with up-to-date guidelines on the management of critically ill patients with COVID-19 (Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019; The Australian and New Zealand Intensive Care Society (ANZICS) COVID-19 Guidelines; Recommandations d'experts SRLF-SFAR-SFMU-GFRUP-SPILF sur la prise en charge en réanimation des patients en période d'épidémie à SARS-CoV2), is of major importance.
Indeed, given the number of intensive care unit (ICU) patients for whom the question of sedation applies during the current COVID-19 outbreak, any sedation practice that would be associated with improved clinical outcomes could have significant economic and public health implications. In this perspective, the rationale supporting inhaled sedation with halogenated agents (such as isoflurane or sevoflurane) as a way to improve lung function, to decrease the inflammatory response, and to possibly improve patient outcome is strong.
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation. The authors, therefore, designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to :
- assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective),
- investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective),
- report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).
This study will be performed in accordance with the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual practice of intravenous sedation | – | Drug: Intravenous sedationThe choice of the intravenous sedative agent, including the type of and dosing of the agent, will be as per the treating clinicians at each center |
| Usual practice of inhaled sedation | – | Drug: Inhaled sedationThe choice of the inhaled sedative agent, including the type of and dosing of the agent, will be as per the treating clinicians at each center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted in ICUrequiring invasive mechanical ventilation and suspected or confirmed COVID19
Key inclusion criteria (4 listed)
- Adult patients (18 years old),
- Admitted to a participating ICU (or any other ICU-like setting that may be deployed as a result of the COVID-19 pandemics, such as in the operating room, post-anesthesia care unit, step-down unit or any COVID-19-specific unit set in response to the pandemics in a participating center),
- Requiring invasive mechanical ventilation,
- With suspected or confirmed COVID-19 on day 0.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intravenous sedationPatients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices | Drug | Usual practice of intravenous sedation |
| Inhaled sedationPatients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices | Drug | Usual practice of inhaled sedation |
Primary outcome
Number of days off the ventilator (VFD28, for ventilator-free days), taking into account death as a competing event
Time frame: Day 28 after inclusion
Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 27 or died prior to day 28, VFDs will be zero. Patients transferred to another hospital or other health care facility will be followed to day 28 to assess this endpoint.
21 secondary outcomes
All-cause mortality
Time frame: Days 7, 14, and 28 after inclusion
Ventilator-free days
Time frame: Days 7 and 14 after inclusion
ICU-free days
Time frame: Day 28 after inclusion
Duration of invasive mechanical ventilation
Time frame: Day 28 after inclusion
Duration of controlled mechanical ventilation
Time frame: Day 28 after inclusion
Physiological measures of lung function
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Physiological measures of lung function
Time frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Development of complications
Time frame: Day 7 from inclusion
Development of complications
Time frame: Day 7 from inclusion
Development of complications
Time frame: Day 7 from inclusion
Duration of vasopressor use
Time frame: Day 28 after inclusion
Duration of renal replacement therapy
Time frame: Day 28 after inclusion
Duration (in days) of any adjuvant therapies
Time frame: Day 7 from inclusion
Duration of continuous neuromuscular blockade
Time frame: Day 28 from inclusion
Type of sedation practices
Time frame: Day 28 from inclusion
Duration of sedation practices
Time frame: Day 28 from inclusion
Modalities of sedation practices
Time frame: Day 28 from inclusion
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 5 Sep 2021.
- Derived from this study: PubMed 33857185Blondonnet R, Quinson A, Lambert C, Audard J, Godet T, Zhai R, Pereira B, Futier E, Bazin JE, Constantin JM, Jabaudon M. Use of volatile agents for sedation in the intensive care unit: A national survey in France. PLoS One. 2021 Apr 15;16(4):e0249889. doi: 10.1371/journal.pone.0249889. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Matthieu Jabaudon study chair
University Hospital, Clermont-Ferrand
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Illness and Sedation, run by University Hospital, Clermont-Ferrand at 12 sites in 5 countries.
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 4 inclusion and 1 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Germany, Switzerland, United States, Spain. 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?
Number of days off the ventilator (VFD28, for ventilator-free days), taking into account death as a competing event (time frame: Day 28 after inclusion). 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 NCT04383730, 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 5 Sep 2021.