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Testing dexamethasone for patients with severe respiratory failure from infections

Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)

Phase 4 Interventional Dr. Negrin University Hospital · NCT04545242

This study is testing if different doses of dexamethasone can help adults on ventilators with severe breathing problems from infections, including COVID-19, to survive and recover better.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment980 (estimated)
Ages18 Years and up
SexAll
SponsorDr. Negrin University Hospital Academic / other
Locations40 sites (Terrassa, Barcelona and 39 other locations)
Trial IDNCT04545242 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of dexamethasone in mechanically ventilated adult patients suffering from acute hypoxemic respiratory failure (AHRF) caused by infections, including COVID-19. It is a multicenter, randomized, controlled, open-label trial conducted in various ICUs across Spain. Participants will be assigned to receive either a high or low dose of dexamethasone for a specified duration, with the primary outcome being 60-day mortality and secondary outcomes focusing on ventilator-free days. The study aims to address the controversial role of corticosteroids in treating AHRF and ARDS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are intubated, mechanically ventilated, and diagnosed with acute hypoxemic respiratory failure due to pulmonary or systemic infections.

Not a fit: Patients with known contraindications to corticosteroids or those participating in other therapeutic clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a proven treatment option for critically ill patients with respiratory failure due to infections, potentially reducing mortality rates.

How similar studies have performed: Other studies have shown mixed results regarding the use of corticosteroids in similar conditions, making this approach both relevant and necessary to explore further.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with a known contraindication to corticosteroids,
* Patient included in another therapeutic clinical trial
* Lack of informed consent

Where this trial is running

Terrassa, Barcelona and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Hypoxemic Respiratory FailureAcute respiratory failureARDSMechanical ventilationInfection
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.