Ongoing Clinical Trials for Acute Respiratory Failure
Acute respiratory failure occurs when the lungs cannot provide enough oxygen to the blood or remove carbon dioxide effectively, requiring immediate medical attention. Currently, there are 4 ongoing clinical trials testing different treatments for patients hospitalized with this serious condition, including medications to reduce inflammation, improve oxygen delivery, and support recovery from severe infections.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Denmark
- France
- Study on the Effects of Methylprednisolone and Isavuconazonium Sulfate in Immunocompromised Patients with Acute Respiratory Failure of Unknown Cause
- Study on Tozorakimab for Patients Hospitalized with Severe Viral Lung Infections Needing Oxygen
- Study on Weaning Patients with Acute Respiratory Failure from High-Flow Nasal Oxygen Therapy Using Oxygen
- Germany
- Greece
- Hungary
- Italy
- Poland
- Romania
- Slovakia
- Spain
- Sweden
Study on Tozorakimab for Patients Hospitalized with Severe Viral Lung Infections Needing Oxygen
This trial is testing a new medication called Tozorakimab for patients hospitalized with severe viral lung infections who need extra oxygen support. The medication is given through an injection into the vein and aims to prevent serious complications such as death or the need for advanced breathing machines by day 28.
Who can join: Adults aged 18 or older who are hospitalized with a viral lung infection and have low oxygen levels in their blood. Specifically, patients need a blood oxygen saturation of 90% or less, or 92% or less combined with chest imaging showing viral infection signs or difficulty breathing. The low oxygen levels must still be present when joining the study.
Who cannot join: Patients who do not require extra oxygen or those already on invasive mechanical ventilation or a heart-lung machine.
What the study focuses on: The trial compares Tozorakimab with a placebo to see how well it prevents death or the need for advanced breathing support within 28 days. Researchers will also monitor how many days patients are alive without needing intensive care or supplemental oxygen, track survival rates up to 60 days, and observe recovery progress including hospital discharge times.
The investigational drug: Tozorakimab is a monoclonal antibody that targets specific proteins involved in inflammation. By reducing lung inflammation, it may help prevent the disease from getting worse and support recovery in patients with severe viral lung infections.
Study on Weaning Patients with Acute Respiratory Failure from High-Flow Nasal Oxygen Therapy Using Oxygen
This study examines the best way to help patients gradually stop using high-flow nasal oxygen therapy, a treatment that delivers oxygen through the nose at high rates to help with breathing difficulties. The goal is to see if a specific weaning protocol can help patients successfully come off this therapy within seven days.
Who can join: Adults aged 18 or older admitted to the intensive care unit for new-onset low blood oxygen levels and currently receiving high-flow nasal oxygen therapy with a flow rate of at least 50 liters per minute and an oxygen level of at least 50%. Patients must have a stable or improving breathing index and have received the therapy for at least 24 hours. They must also have health insurance coverage and provide written consent.
Who cannot join: Patients with a different breathing problem than the one being studied, those outside the specified age range, or individuals considered vulnerable and needing extra protection.
What the study focuses on: The main goal is to increase the likelihood of successfully weaning patients from high-flow nasal oxygen by day 7, meaning they can stay off the therapy for more than 48 hours without needing additional breathing support. The study also monitors weaning rates by day 28, time to final weaning, any need for intubation or other breathing support, breathing comfort levels, and length of stay in the intensive care unit.
The investigational approach: This trial tests a specific weaning protocol rather than a drug. High-flow nasal oxygen therapy provides constant oxygen flow through a nasal tube, helping maintain adequate oxygen levels while reducing the work of breathing.
Study on the Effects of Dexamethasone in Adults with Acute Respiratory Failure Due to Infections, Including COVID-19
This trial compares different doses of dexamethasone, a medication that reduces inflammation, in patients experiencing severe breathing difficulties due to infections like COVID-19. The study aims to determine which dose is more effective in improving survival and reducing the need for breathing machines.
Who can join: Adults aged 18 or older who are intubated and on mechanical ventilation due to sudden-onset low blood oxygen levels. Patients must have a specific oxygen measurement of 300 mmHg or less for at least 6 hours, and the breathing difficulties must be caused by a lung or body-wide infection.
Who cannot join: Patients who do not have low blood oxygen levels requiring breathing support, those under 18 years old, or individuals from vulnerable populations.
What the study focuses on: The primary goals are to see how different doses of dexamethasone affect the number of deaths within 60 days and the number of days patients can live without ventilator support within 28 days. The study also tracks how long patients stay on ventilators, their hospital length of stay, overall survival rates, and the presence of viral genetic material over time to understand infection progression.
The investigational drug: Dexamethasone is a corticosteroid that helps reduce inflammation and modulate the immune response. The trial tests two dosing approaches: a higher dose of 20 mg for the first 5 days followed by 10 mg for the next 5 days, compared to a lower dose of 6 mg daily for up to 10 days.
Study on the Effects of Methylprednisolone and Isavuconazonium Sulfate in Immunocompromised Patients with Acute Respiratory Failure of Unknown Cause
This study is designed for patients with weakened immune systems who develop sudden breathing difficulties without a clear cause. It tests whether using steroids and antifungal medication can improve survival and health outcomes in these vulnerable patients.
Who can join: Adults between 18 and 90 years old with weakened immune systems due to immunosuppressive drugs, organ transplant, cancer, or primary immune deficiency. Patients must be admitted to intensive care with breathing difficulties shown by rapid breathing, bluish skin color, or needing high levels of oxygen support or breathing machines. The cause of breathing problems must remain unknown 24 hours after hospital admission, and patients must have been hospitalized for at least 24 hours.
Who cannot join: Patients whose breathing difficulties have a known cause, those with normal immune systems, individuals outside the age range, or those not meeting the specific trial criteria.
What the study focuses on: The primary goal is to reduce death rates by day 90. The study also monitors intensive care unit mortality, hospital mortality, the occurrence of infections or complications, and quality of life and mental health at six months using standardized questionnaires.
The investigational drugs: Methylprednisolone is a steroid that reduces lung inflammation by decreasing the production of inflammatory substances. Isavuconazonium sulfate (CRESEMBA) is an antifungal medication that works by disrupting fungal cell membranes, helping to prevent or treat fungal infections that can threaten immunocompromised patients. Treatment lasts up to 14 days or until discharge from intensive care.
Summary
The four ongoing clinical trials for acute respiratory failure reflect diverse treatment approaches tailored to different patient populations and underlying causes. The largest trial, testing Tozorakimab, spans 14 European countries, indicating significant international collaboration in studying treatments for viral lung infections. Two trials focus specifically on France, while one is conducted in Spain, showing concentrated research efforts in these regions.
The studies explore different therapeutic strategies: anti-inflammatory medications like Tozorakimab and dexamethasone for infection-related breathing difficulties, combination therapy with steroids and antifungals for immunocompromised patients, and a weaning protocol to help patients transition off high-flow oxygen support. This variety reflects the complex nature of the condition and the need for treatments addressing different patient needs and disease mechanisms.
Notably, three of the four trials involve testing medications that reduce inflammation, highlighting the important role inflammation plays in breathing difficulties. The focus on specific patient groups, such as those with weakened immune systems or viral infections, demonstrates efforts to personalize treatment approaches based on underlying health conditions.
