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Steroid dose showdown: can more dexamethasone save lives in respiratory failure?

NCT ID NCT04545242

Disease control Sponsor: Hospital Universitario de Gran Canaria Doctor Negrín Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether a higher dose of dexamethasone works better than a lower dose for adults on ventilators with acute hypoxemic respiratory failure caused by infections, including COVID-19. The trial enrolls 980 patients in Spanish intensive care units and randomly assigns them to receive either 6 mg per day for 10 days or a higher dose of 20 mg per day for 5 days followed by 10 mg per day for 5 days. The main goal is to see which dose leads to better 60-day survival and more days free from the ventilator.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexamethasone, a steroid that calms inflammation
What this could lead to
If higher doses work better, doctors could adjust steroid treatment for patients on ventilators with severe respiratory failure from infections. This may help more people survive and spend fewer days on a breathing machine.
What could go wrong
Steroids can raise the risk of infections and other complications, and the right dose is still unclear. The trial may show no difference between doses, or the results may not apply to all patients with respiratory failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

980 people

The number who actually took part.

Started

Jul 2020

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome acute respiratory failure Infections respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute hypoxemic respiratory failure

Contacts and locations

Locations

  • Clínica Universidad de Navarra

    Pamplona, 31008, Spain

  • Complejo Asistencial Universitario de León (ICU)

    León, 24001, Spain

  • Complejo Hospitalario Universitario de Albacete (ICU)

    Albacete, 02006, Spain

  • Complejo Hospitalario Universitario de Santiago (Anesthesia)

    Santiago de Compostela, La Coruña, 15706, Spain

  • Hospital Clinic de Barcelona (AVI)

    Barcelona, 08036, Spain

  • Hospital Clinic de Barcelona (Cardiac ICU)

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia (Anesthesia)

    Valencia, 46010, Spain

  • Hospital Clinico Universitario de Valencia (ICU)

    Valencia, 46010, Spain

  • Hospital Clínic (Hepatic ICU)

    Barcelona, 08036, Spain

  • Hospital Clínic de Barcelona (Anesthesia)

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario San Carlos (ICU)

    Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valladolid (Anesthesia)

    Valladolid, 47003, Spain

  • Hospital General El Bierzo (ICU)

    Ponferrada, León, 24404, Spain

  • Hospital General La Mancha Centro (ICU)

    Alcázar de San Juan, Ciudad Real, 13600, Spain

  • Hospital General de Ciudad Real (ICU)

    Ciudad Real, 13005, Spain

  • Hospital General de Segovia (ICU)

    Segovia, 40002, Spain

  • Hospital Nuestra Señora del Prado (ICU)

    Talavera de la Reina, Toledo, 45600, Spain

  • Hospital Universitario Doce de Octubre (ICU)

    Madrid, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz (ICU)

    Madrid, 28040, Spain

  • Hospital Universitario La Paz (Anesthesia)

    Madrid, 28046, Spain

  • Hospital Universitario La Paz (ICU)

    Madrid, 28046, Spain

  • Hospital Universitario La Princesa (ICU)

    Madrid, 28006, Spain

  • Hospital Universitario Montecelo (Anesthesia)

    Pontevedra, 36071, Spain

  • Hospital Universitario Mutua Terrassa (ICU)

    Terrassa, Barcelona, 08221, Spain

  • Hospital Universitario Nuestra Señora de Candelaria (ICU)

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Puerta de Hierro (ICU)

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal (Anesthesia)

    Madrid, 28034, Spain

  • Hospital Universitario Regional de Malaga Carlos Haya (ICU)

    Málaga, 29010, Spain

  • Hospital Universitario Río Hortega (Anesthesia)

    Valladolid, 47012, Spain

  • Hospital Universitario Río Hortega (ICU)

    Valladolid, 47012, Spain

  • Hospital Universitario Severo Ochoa (ICU)

    Leganés, Madrid, 28911, Spain

  • Hospital Universitario Virgen de Arrixaca (Anesthesia)

    Murcia, 30120, Spain

  • Hospital Universitario Virgen de Arrixaca (ICU)

    Murcia, 30120, Spain

  • Hospital Universitario de A Coruña (ICU)

    A Coruña, 15006, Spain

  • Hospital Universitario de Cruces (Anesthesia)

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital Universitario de Cruces (ICU)

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital Universitario de Getafe (ICU)

    Getafe, Madrid, 28905, Spain

  • Hospital Universitario del Henares (ICU)

    Coslada, Madrid, 28822, Spain

  • Hospital Virgen de la Concha (ICU)

    Zamora, 49022, Spain

  • Hospital Virgen de la Luz (ICU)

    Cuenca, 16002, Spain

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