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Study on the Effects of Dexamethasone in Adults with Acute Respiratory Failure Due to Infections, Including COVID-19

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication dexamethasone in patients who are experiencing Acute Hypoxemic Respiratory Failure, which can occur due to infections like COVID-19. Acute Hypoxemic Respiratory Failure is a condition where the lungs cannot provide enough oxygen to the blood, often requiring support from a ventilator. The trial aims to compare the outcomes of using higher doses versus lower doses of dexamethasone, a medication that helps reduce inflammation, in these patients.

The purpose of the study is to understand how different doses of dexamethasone affect the number of deaths within 60 days and the number of days patients can live without needing a ventilator within 28 days. The study will involve patients who are already on ventilators due to severe breathing difficulties caused by infections. Participants will receive either a higher or lower dose of dexamethasone through an injection, and their progress will be monitored over time to see how the treatment impacts their recovery and survival.

Throughout the study, researchers will collect information on various outcomes, such as the number of days patients spend on ventilators, their length of stay in the hospital, and their overall survival rates. This information will help determine the most effective dose of dexamethasone for treating patients with severe respiratory failure due to infections. The study will also track the presence of viral RNA over time to understand the infection's progression and response to treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age (18 years or older) and the need for ventilatory support due to acute hypoxemic respiratory failure.

    The condition must have a pulmonary or systemic infectious cause, including COVID-19.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to receive either a higher dose or a lower dose of dexamethasone.

    The higher dose consists of 20 mg for the first 5 days, followed by 10 mg for the next 5 days.

    The lower dose consists of 6 mg daily for up to 10 days.

    The medication is administered as a solution for injection.

  3. Step 3

    Treatment period

    During the treatment period, the effects of the medication are monitored.

    The primary focus is on the number of deaths at 60 days after randomization and the number of days alive without ventilator support at 28 days.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any changes in their condition, including the duration of mechanical ventilation and length of hospital stay.

    Clinical status information is collected at 60 days, even if participants are discharged from the hospital.

  5. Step 5

    End of study

    The study is estimated to conclude by December 31, 2024.

    Final outcomes include all-cause hospital mortality and secondary measures such as the number of ventilator-free days and mortality at 28 days.

Who can join the trial?

4 criteria

  • Must be **18 years or older**.
  • Must be **intubated and mechanically ventilated**, which means needing a machine to help with breathing at the time of screening.
  • Must have a **sudden onset of Acute Hypoxemic Respiratory Failure (AHRF)**. This is defined by a specific measurement called **PaO2/FiO2 ratio** being **300 mmHg or less** for at least 6 hours from diagnosis. This measurement helps assess how well oxygen is being transferred from the lungs to the blood. The minimum accepted settings for this measurement are a **PEEP** (a pressure setting on the ventilator) of **5 cmH2O** and an **FiO2** (the concentration of oxygen being given) of **0.3**. If the patient has **Acute Respiratory Distress Syndrome (ARDS)**, it is defined by the Berlin criteria, which include having pneumonia or worsening breathing symptoms, seeing changes in both lungs on a chest x-ray or CT scan, not having high blood pressure in the left atrium of the heart or signs of left heart failure, and having low oxygen levels as defined by the PaO2/FiO2 ratio.
  • Must have AHRF caused by a **pulmonary or systemic infection**, which means an infection in the lungs or throughout the body.

Who cannot join the trial?

3 criteria

  • Patients who do not have Acute Hypoxemic Respiratory Failure cannot participate. This is a condition where the lungs cannot provide enough oxygen to the blood.
  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups who may need special protection, like pregnant women or people with certain disabilities.
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Investigated drugs

Dexamethasone is a medication used in this clinical trial to treat patients with acute hypoxemic respiratory failure, including those with acute respiratory distress syndrome (ARDS) caused by infections such as COVID-19. The trial is comparing the effects of different doses of dexamethasone on the number of deaths within 60 days and the number of days patients are alive without needing ventilator support within 28 days. Dexamethasone is a type of corticosteroid that helps reduce inflammation in the body, which can be beneficial in managing severe respiratory conditions.

What is already known about the treatment

Dexamethasone – This medication is administered intravenously and is currently being studied for its effectiveness in treating acute hypoxemic respiratory failure, including conditions like ARDS caused by infections such as COVID-19. Dexamethasone is a well-established medication in medical literature, primarily used for its anti-inflammatory and immunosuppressant properties. It is classified as a corticosteroid and works by reducing inflammation and modulating the immune response at the molecular level. The clinical trial aims to compare different doses of dexamethasone to determine their impact on survival rates and the need for ventilator support in affected patients.

Investigated diseases

Acute Hypoxemic Respiratory Failure – This condition occurs when the lungs cannot provide enough oxygen to the blood, leading to low oxygen levels in the body. It often results from severe lung diseases or infections, such as pneumonia or COVID-19. The condition can cause difficulty breathing, rapid breathing, and a feeling of not getting enough air. As it progresses, it may require medical interventions like oxygen therapy or mechanical ventilation to support breathing. The severity can vary, and it often requires close monitoring in a hospital setting.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519759-27-00Protocol codeDEXA-REFINE-COVID-19Estimated enrolment980 patientsSponsorConsorcio Centro De Investigacion Biomedica En Red

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