Acute Hypoxemic Respiratory FailurePhase 4DEXA-REFINENCT04545242
Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
A Phase 4 study testing Dexamethasone in people with Acute Hypoxemic Respiratory Failure, run by Hospital Universitario de Gran Canaria Doctor Negrín at 40 sites in Spain.
Trial summary
Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 40 sitesSpain
- Study dates
- 6 Jul 2020to 30 Dec 2020
- Phase
- Phase 4
- 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 or older;
- intubated and mechanically ventilated;
- acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
- Pulmonary or systemic infectious etiology of AHRF.
Who cannot join
- Patients with a known contraindication to corticosteroids,
- Patient included in another therapeutic clinical trial
- Lack of informed consent
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Spain40 sites
Hospital Universitario de A Coruña (ICU)
A Coruña, 15006
Complejo Hospitalario Universitario de Albacete (ICU)
Albacete, 02006
Hospital General La Mancha Centro (ICU)
Alcázar de San Juan, Ciudad Real, 13600
Hospital Universitario de Cruces (Anesthesia)
Barakaldo, Vizcaya, 48903
Hospital Universitario de Cruces (ICU)
Barakaldo, Vizcaya, 48903
Hospital Clinic de Barcelona (AVI)
Barcelona, 08036
Hospital Clinic de Barcelona (Cardiac ICU)
Barcelona, 08036
Hospital Clínic (Hepatic ICU)
Barcelona, 08036
Hospital Clínic de Barcelona (Anesthesia)
Barcelona, 08036
Hospital General de Ciudad Real (ICU)
Ciudad Real, 13005
Hospital Universitario del Henares (ICU)
Coslada, Madrid, 28822
Hospital Virgen de la Luz (ICU)
Cuenca, 16002
Hospital Universitario de Getafe (ICU)
Getafe, Madrid, 28905
Hospital Universitario Severo Ochoa (ICU)
Leganés, Madrid, 28911
Complejo Asistencial Universitario de León (ICU)
León, 24001
Hospital Universitario La Princesa (ICU)
Madrid, 28006
Hospital Universitario Ramón y Cajal (Anesthesia)
Madrid, 28034
Hospital Clínico Universitario San Carlos (ICU)
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz (ICU)
Madrid, 28040
Hospital Universitario Doce de Octubre (ICU)
Madrid, 28041
Hospital Universitario La Paz (Anesthesia)
Madrid, 28046
Hospital Universitario La Paz (ICU)
Madrid, 28046
Hospital Universitario Puerta de Hierro (ICU)
Majadahonda, Madrid, 28222
Hospital Universitario Regional de Malaga Carlos Haya (ICU)
Málaga, 29010
Hospital Universitario Virgen de Arrixaca (Anesthesia)
Murcia, 30120
Hospital Universitario Virgen de Arrixaca (ICU)
Murcia, 30120
Clínica Universidad de Navarra
Pamplona, 31008
Hospital General El Bierzo (ICU)
Ponferrada, León, 24404
Hospital Universitario Montecelo (Anesthesia)
Pontevedra, 36071
Hospital Universitario Nuestra Señora de Candelaria (ICU)
Santa Cruz de Tenerife, 38010
Complejo Hospitalario Universitario de Santiago (Anesthesia)
Santiago de Compostela, La Coruña, 15706
Hospital General de Segovia (ICU)
Segovia, 40002
Hospital Nuestra Señora del Prado (ICU)
Talavera de la Reina, Toledo, 45600
Hospital Universitario Mutua Terrassa (ICU)
Terrassa, Barcelona, 08221
Hospital Clinico Universitario de Valencia (Anesthesia)
Valencia, 46010
Hospital Clinico Universitario de Valencia (ICU)
Valencia, 46010
Hospital Clínico Universitario de Valladolid (Anesthesia)
Valladolid, 47003
Hospital Universitario Río Hortega (Anesthesia)
Valladolid, 47012
Hospital Universitario Río Hortega (ICU)
Valladolid, 47012
Hospital Virgen de la Concha (ICU)
Zamora, 49022
About this study
Official title: Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)
Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.
Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.
Read the detailed description
Acute hypoxemic respiratory failure (AHRF), and its more severe form termed the acute respiratory distress syndrome (ARDS), is a catastrophic illness of multifactorial etiology characterized by a severe inflammatory process of the lung leading to hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of AHRF and ARDS. Translational research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of AHRF.2 Glucocorticoid receptor-mediated downregulation of systemic and pulmonary inflammation is essential to accelerate disease resolution and restore tissue homeostasis, and can be enhanced with glucocorticoid treatment.
The COVID-19 pandemic is a critical moment for the world, in which even industrially advanced countries have rapidly reached intensive care units (ICUs) saturation, and intensivists are forced to make difficult ethical decisions that are uncommon outside war zones. As with other bacterial or viral infections, severe pneumonia is the main condition leading to AHRF and ARDS requiring weeks of MV with high mortality (35-55%) in critically ill patients. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties.3 Corticosteroids have been off patent for greater than 20 years, they are cheap, and globally equitable. However, the efficacy of corticosteroids in AHRF (including ARDS) caused by infections remains controversial.
Only two large randomized clinical trials (RCT) have shown that the administration of dexamethasone is able to reduce mortality in patients with AHRF. Villar et al in Spain observed that moderate doses of dexamethasone (10-20 mg/d x 10 days) caused a 15% absolute reduction of 60-day mortality in patients with established moderate-to-severe ARDS from multiple etiologies. Horby et al in the RECOVERY trial in Great Britain reported that dexamethasone at low doses (6 mg/d x 10 days) reduced 28-day mortality in patients with AHRF caused by COVID-19. These findings confirmed that corticosteroid therapy is associated with a sizable reduction in duration of MV and hospital mortality. These two RCTs will change clinical practice for the management of AHRF and ARDS. However, there is a reasonable doubt whether dexamethasone at moderate doses (10-20 mg/d) would cause a greater reduction in mortality than 6 mg/d. Our goal in this study is to respond this question.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Dexamethasone
- Keywords
- Acute respiratory failure, ARDS, Mechanical ventilation, Infection
- Medical subject headings
- Respiratory Insufficiency, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron, Dexasone, Diodex
Intravenous dexamethasone (low vs. moderate doses) during 10 days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone (low dose) | Active comparator | Dexamethasone: 6 mg/iv/day during 10 days. Receives: Drug: Dexamethasone |
| Dexamethasone (moderate dose) | Active comparator | Dexamethasone: 20 mg/iv/ daily from day of randomization (day 1) during 5 days, followed by 10 mg/iv/ daily from Day 6 to Day 10 of randomization. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day mortality
All-cause mortality at 60 days after randomization
Measured: 60 days
Secondary outcomes (1)
Ventilator-free days
Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after randomization. For patients ventilated 28 days or longer and for subjects who die, VFD is 0.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start6 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
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 Hypoxemic Respiratory FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with AHRF (including ARDS) caused by confirmed bacterial or viral infections.
- Masking
- None (open label)
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Collaborators
- Li Ka Shing Knowledge Institute, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Principal investigator, Jesus Villar, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Jesús Villar, MD, Principal investigator, Hospital Universitario Dr. Negrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545242
- Sponsor's protocol ID
- ICI20-00062
- Acronym
- DEXA-REFINE
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7.
PubMed 32043986RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.
PubMed 32678530
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)
- ClinicalTrials.gov ID
- NCT04545242
- Acronym / sponsor ID
- DEXA-REFINE / ICI20-00062
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- Acute respiratory failure, ARDS, Mechanical ventilation, Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- Li Ka Shing Knowledge Institute, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 10 Sep 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.
Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.
Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.
Detailed description
Acute hypoxemic respiratory failure (AHRF), and its more severe form termed the acute respiratory distress syndrome (ARDS), is a catastrophic illness of multifactorial etiology characterized by a severe inflammatory process of the lung leading to hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of AHRF and ARDS. Translational research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of AHRF.2 Glucocorticoid receptor-mediated downregulation of systemic and pulmonary inflammation is essential to accelerate disease resolution and restore tissue homeostasis, and can be enhanced with glucocorticoid treatment.
The COVID-19 pandemic is a critical moment for the world, in which even industrially advanced countries have rapidly reached intensive care units (ICUs) saturation, and intensivists are forced to make difficult ethical decisions that are uncommon outside war zones. As with other bacterial or viral infections, severe pneumonia is the main condition leading to AHRF and ARDS requiring weeks of MV with high mortality (35-55%) in critically ill patients. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties.3 Corticosteroids have been off patent for greater than 20 years, they are cheap, and globally equitable. However, the efficacy of corticosteroids in AHRF (including ARDS) caused by infections remains controversial.
Only two large randomized clinical trials (RCT) have shown that the administration of dexamethasone is able to reduce mortality in patients with AHRF. Villar et al in Spain observed that moderate doses of dexamethasone (10-20 mg/d x 10 days) caused a 15% absolute reduction of 60-day mortality in patients with established moderate-to-severe ARDS from multiple etiologies. Horby et al in the RECOVERY trial in Great Britain reported that dexamethasone at low doses (6 mg/d x 10 days) reduced 28-day mortality in patients with AHRF caused by COVID-19. These findings confirmed that corticosteroid therapy is associated with a sizable reduction in duration of MV and hospital mortality. These two RCTs will change clinical practice for the management of AHRF and ARDS. However, there is a reasonable doubt whether dexamethasone at moderate doses (10-20 mg/d) would cause a greater reduction in mortality than 6 mg/d. Our goal in this study is to respond this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with AHRF (including ARDS) caused by confirmed bacterial or viral infections.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone (low dose) | Active comparator | Drug: DexamethasoneDexamethasone: 6 mg/iv/day during 10 days. |
| Dexamethasone (moderate dose) | Active comparator | Drug: DexamethasoneDexamethasone: 20 mg/iv/ daily from day of randomization (day 1) during 5 days, followed by 10 mg/iv/ daily from Day 6 to Day 10 of randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older;
- intubated and mechanically ventilated;
- acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
- Pulmonary or systemic infectious etiology of AHRF.
Key exclusion criteria (3 listed)
- Patients with a known contraindication to corticosteroids,
- Patient included in another therapeutic clinical trial
- Lack of informed consent
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 |
|---|---|---|
| DexamethasoneAlso: Decadron, Dexasone, DiodexIntravenous dexamethasone (low vs. moderate doses) during 10 days | Drug | Dexamethasone (low dose), Dexamethasone (moderate dose) |
Primary outcome
60-day mortality
Time frame: 60 days
All-cause mortality at 60 days after randomization
1 secondary outcome
Ventilator-free days
Time frame: 28 days
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 18 Sep 2026.
- Background: PubMed 32043986Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7.
- Background: PubMed 32678530RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.
- Individual participant dataSharing planned: No
Related trials for Acute Hypoxemic Respiratory Failure
Recruiting
Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
RecruitingPhase 2
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Acute Hypoxemic Respiratory Failure
Recruiting
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure
Active, not recruiting
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
Respiratory Failure, Acute Hypoxemic Respiratory Failure
Not yet recruiting
Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients
Acute Hypoxemic Respiratory Failure, High-Flow Nasal Cannula Therapy
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.
Jesús Villar, MD principal investigator
Hospital Universitario Dr. Negrin
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Acute Hypoxemic Respiratory Failure, run by Hospital Universitario de Gran Canaria Doctor Negrín at 40 sites in Spain.
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 3 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
60-day mortality (time frame: 60 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 NCT04545242, 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 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.