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

3 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Rio Hortega	Valladolid	Spain
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Fqxlhzbsj Psjd Ly Iedakfxxwvyry Bhcamxadb Dxf Hhwwqfdw Uwolsrntpjlfp Ln Pvu	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	06.07.2021

Trial locations

Investigated drugs:

Dexamethasone Sodium Phosphate

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.

Investigated diseases:

Acute respiratory failure

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 ID:

2024-519759-27-00

Protocol code:

DEXA-REFINE-COVID-19

NCT ID:

NCT04545242

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?