Ongoing Clinical Trials for Acute Respiratory Distress Syndrome
This article presents 13 ongoing clinical trials investigating new treatments for Acute Respiratory Distress Syndrome, a severe lung condition that causes difficulty breathing. These trials are taking place across Europe, testing various medications including inhaled anesthetics, anti-inflammatory drugs, and antifibrotic agents. Researchers are exploring whether these treatments can help patients breathe without ventilator support sooner, reduce inflammation, and improve overall survival rates.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Finland
- France
- A Study of Inhaled Sevoflurane Compared to Standard Intravenous Sedation (Dexmedetomidine, Midazolam, or Propofol) in ICU Patients at Risk of Acute Respiratory Distress Syndrome
- Study on FX06 for Improving Acute Respiratory Distress Syndrome in Patients
- Study of High-Dose Vitamin C (Ascorbic Acid) Compared to Placebo in Patients with Sepsis and Acute Respiratory Distress Syndrome (ARDS) in Intensive Care
- Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)
- Germany
- Study on FX06 for Improving Acute Respiratory Distress Syndrome in Patients
- Study on Imlifidase for Patients with Severe ANCA-Associated Vasculitis and Lung Bleeding
- Study on the Effectiveness and Safety of Reparixin for Adults with Acute Respiratory Distress Syndrome
- Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)
- Hungary
- Italy
- Study on Anakinra for Patients with Non-COVID-19 Related Acute Respiratory Distress Syndrome (ARDS)
- Study on Pirfenidone for Preventing Lung Fibrosis in Patients with Acute Respiratory Distress Syndrome (ARDS)
- Study on the Effectiveness and Safety of Reparixin for Adults with Acute Respiratory Distress Syndrome
- Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)
- Lithuania
- Netherlands
- Romania
- Spain
- Study of inhaled aprotinin for treatment of moderate to severe acute respiratory distress syndrome
- Study on FX06 for Improving Acute Respiratory Distress Syndrome in Patients
- Study on the Effects of Metoprolol in Patients with Acute Respiratory Distress Syndrome (ARDS)
- Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)
A Study of Inhaled Sevoflurane Compared to Standard Intravenous Sedation (Dexmedetomidine, Midazolam, or Propofol) in ICU Patients at Risk of Acute Respiratory Distress Syndrome
This study is being conducted in France and focuses on ICU patients at risk of developing the condition. Participants must be adults between 18 and 65 years of age who are on mechanical ventilation and require sedation for at least four hours. They should have at least one known risk factor for the syndrome with a Lung Injury Prediction Score of 4 or higher. Patients must also be affiliated with the French Social Security system.
Exclusion criteria include current diagnosis of the condition, pregnancy, breastfeeding, known allergies to sevoflurane, severe liver disease, uncontrolled high blood pressure, recent major surgery within 14 days, severe kidney disease requiring dialysis, unstable heart conditions, brain injury, and drug or alcohol dependency.
The main focus of this trial is to compare inhaled sevoflurane with standard intravenous sedation medications. The study aims to determine if inhaled sevoflurane can improve oxygen levels in the blood better than traditional medications such as dexmedetomidine, midazolam, or propofol. Researchers will monitor lung function, oxygen levels, and signs of lung problems, as well as track infections, time spent on breathing machines, and length of ICU stay.
The investigational drug is sevoflurane, an inhaled anesthetic that is delivered through a breathing system rather than through an IV line. It may offer protective effects on lung function and allows for better control of sedation levels.
Study on Anticoagulation Strategies with Heparin, Enoxaparin, and Argatroban for Patients with Respiratory or Circulatory Failure on ECMO Support
This trial is taking place in Austria and focuses on patients who need Extracorporeal Membrane Oxygenation support due to serious respiratory or circulatory conditions. Patients must be older than 18 years and either require ECMO support or have started ECMO therapy within the last 12 hours while being in an Intensive Care Unit.
The trial compares three medications that help prevent blood clots during ECMO therapy: Unfractionated Heparin, Argatroban, and Enoxaparin. The main goal is to see how these medications affect the occurrence of blood clots and bleeding events.
Participants will be randomly assigned to receive one of the three medications. Throughout the study, researchers will monitor for blood clots such as pulmonary embolism and deep vein thrombosis, as well as any bleeding events. Regular imaging tests and ultrasound examinations will be used to detect any complications. The study aims to determine which medication is most effective in preventing blood clots without causing significant bleeding.
Study on Imlifidase for Patients with Severe ANCA-Associated Vasculitis and Lung Bleeding
This study is being conducted in Germany and examines a specific type of vasculitis that involves severe lung bleeding. Participants must have a clinical diagnosis of ANCA-associated vasculitis with pulmonary hemorrhage confirmed by chest imaging and specific clinical findings. They must have an ANCA titer of 50 or higher measured within 14 days before joining the study. Female participants must be post-menopausal.
Patients with other serious medical conditions, pregnancy or breastfeeding status, recent participation in other trials, known allergies to the study medication, severe liver or kidney disease, active infections, recent cancer history, or inability to follow study procedures are excluded.
The trial tests Idefirix, which contains imlifidase, given through intravenous infusion alongside standard care. The study aims to evaluate how quickly ANCA antibody levels decrease after treatment and monitor lung and kidney function, overall safety, and mortality rates. Imlifidase works by breaking down specific proteins in the immune system that are involved in this disease, helping to reduce inflammation and damage.
Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)
This trial is taking place across multiple countries including Belgium, Hungary, Romania, Czechia, Spain, Netherlands, Germany, Bulgaria, France, and Italy. It focuses on patients with moderate-to-severe condition caused by pneumonia or other infections. Patients must be 18 years or older and have the condition confirmed within seven days of an infection. They must be receiving respiratory support such as mechanical ventilation, CPAP, or high-flow oxygen therapy.
For inclusion, patients must have an inflammatory phenotype shown by high levels of inflammatory markers, dependence on vasopressors, or specific blood chemistry values. Both male and female participants can join, and informed consent must be provided by the patient or their legal representative. During the study, participants must agree to use reliable birth control methods.
The study tests Recombinant Human Plasma Gelsolin administered through intravenous infusion, comparing its effects with a placebo. The main focus is on survival rates and the number of days patients can breathe without ventilator assistance. Researchers will monitor various outcomes including ventilator-free days, hospital stay duration, and overall safety by tracking any new or worsening health issues.
Study of High-Dose Vitamin C (Ascorbic Acid) Compared to Placebo in Patients with Sepsis and Acute Respiratory Distress Syndrome (ARDS) in Intensive Care
This French study examines whether high-dose vitamin C can help patients with sepsis complicated by the condition. Participants must be at least 18 years old and admitted to the ICU with confirmed or suspected infection. They must be receiving continuous intravenous vasopressors and breathing support through various methods including high-flow oxygen therapy, CPAP, NIV, or invasive ventilation.
Patients must have specific oxygen level measurements and breathing support settings that meet the study criteria. The condition must have started within one week of a known medical problem, with lung imaging showing shadows on both sides and no signs of heart failure. Patients must be able to provide written informed consent or have a representative who can provide it, and they must have health insurance or universal health coverage.
Exclusion criteria include age below 18 or above 65 years, known allergic reactions to vitamin C, current participation in other trials, kidney failure requiring dialysis before admission, severe liver disease, terminal illness with life expectancy less than 28 days, history of kidney stones, recent high-dose vitamin C supplementation, and inability to provide informed consent.
The study compares high-dose intravenous vitamin C with a placebo, monitoring patients for 28 days. The main goal is to determine if vitamin C can reduce the chances of death or ongoing organ problems. Vitamin C acts as an antioxidant that may help protect cells from damage and support the immune system during severe illness.
Study of inhaled aprotinin for treatment of moderate to severe acute respiratory distress syndrome
This Spanish trial studies inhaled aprotinin for treating moderate or severe cases. Patients must be diagnosed with the condition within 48 hours and be using a breathing tube and ventilator. Chest imaging and oxygen level tests must be performed within the same 24-hour period. Participants must be 18 years or older, with both men and women eligible to participate.
Exclusion criteria include age below 18 or above 65 years, pregnancy or breastfeeding, history of allergic reactions to aprotinin or similar medications, current participation in other trials, severe liver or kidney disease, uncontrolled bleeding disorders, active infections requiring antibiotics, major surgery within 30 days, severe uncontrolled heart conditions, history of blood clotting disorders, recent use of blood-thinning medications, and any condition that might interfere with study results.
The study tests inhaled aprotinin, a substance that helps control inflammation by blocking certain proteins in the body. Patients receive either aprotinin or a saline solution through inhalation. The study monitors how long patients need breathing machines, tracks their health status, and observes their recovery over several months. Regular checks of blood samples, vital signs, and general health ensure patient safety throughout the treatment period.
Study on [68Ga]FAPI-46 to Detect Fibroblast Activity in Patients with Non-Resolving Acute Respiratory Distress Syndrome (ARDS) in the ICU
This trial in the Netherlands focuses on patients with non-resolving cases, meaning the condition does not improve over time. Adult patients must be older than 19 years and on mechanical ventilation. On the fifth day after diagnosis, they must meet criteria for non-resolving condition with at least one of the following: P/F ratio less than 200 mmHg, PEEP of 12 cmH2O or more, or static lung compliance less than 50 ml/cmH2O. Patients must be considered safe for transport by their doctor, and informed consent must be signed by the patient or their legal representative. For patients with COVID-19, a specific virus test result is required.
The study uses a special imaging technique called PET/CT with an injection of [68Ga]FAPI-46 to observe the activity of cells involved in forming fibrous tissue in the lungs. The purpose is to understand how this cell activity relates to patient recovery, including survival after 28 days, ventilator-free days, and length of ICU stay. The imaging agent helps doctors see how active fibroblasts are, which might help predict how the condition will progress.
Study on Anakinra for Patients with Non-COVID-19 Related Acute Respiratory Distress Syndrome (ARDS)
This Italian trial studies anakinra for treating cases not related to COVID-19. Patients must be 18 years or older and admitted to the ICU with a diagnosis of moderate to severe condition within 48 hours. They must meet the Berlin criteria, with symptoms starting within one week of an injury or new breathing problems, and specific chest scan findings not due to other causes like heart failure.
Patients must have an inflammatory profile based on at least one of the following: high levels of inflammatory markers in the blood, need for vasopressors for at least one hour, or low bicarbonate or high lactate levels. They must provide informed consent and have a negative COVID-19 test.
The study evaluates anakinra’s effectiveness in increasing the number of days patients can breathe without ventilator assistance. Anakinra is administered through subcutaneous injection and works by blocking interleukin-1, a protein that plays a key role in inflammation. The trial monitors various health outcomes including survival rates, improvements in lung function, organ function using the SOFA score, and overall safety.
Study on Pirfenidone for Preventing Lung Fibrosis in Patients with Acute Respiratory Distress Syndrome (ARDS)
This Italian study tests pirfenidone for preventing lung scarring in patients with the condition. Patients must have moderate or severe condition as defined by the Berlin definition and an inflammatory phenotype shown by high inflammatory markers, vasopressor dependence for at least one hour, or specific blood chemistry values. Consent must be provided by the patient, legal representative, or as indicated by an ethical committee. The study is open to both male and female participants.
Exclusion criteria include known allergy to Pirfenidone, current participation in another trial, severe liver or kidney disease, pregnancy or breastfeeding, recent heart attack, severe asthma, blood disorders, immune system disorders, and severe depression.
Pirfenidone is provided as film-coated tablets taken orally or through a feeding tube. The main goal is to increase ventilator-free days by day 28 compared to a placebo group. The study monitors ICU-free days, SOFA scores, hospital stay length, lung condition changes on CT scans, and mortality rates. Follow-up evaluations include pulmonary function tests, a six-minute walk test, quality of life questionnaires, and heart function assessment. Pirfenidone works by inhibiting proteins that lead to inflammation and scarring in the lungs.
Study on Premedication with Ketamine or Fentanyl for Patients with Respiratory Distress Syndrome Receiving Surfactant Treatment
This Finnish trial investigates premedication with ketamine or fentanyl for patients receiving surfactant treatment. Babies must be born at a gestational age of at least 26 weeks and have respiratory insufficiency managed with non-invasive support. They must need oxygen to maintain proper oxygen levels and require surfactant treatment. Both male and female babies can participate.
The study compares fentanyl citrate and esketamine hydrochloride as premedication options before less invasive surfactant administration. Both medications are given through an intravenous injection in a single, quick dose. The trial aims to determine which medication is associated with fewer adverse events and is more effective and safe for the procedure.
Throughout the procedure, vital signs including heart rate, blood pressure, and oxygen levels are closely monitored. Secondary outcomes include procedure duration, number of catheter placement attempts, and pain assessment. Ketamine is used for its sedative and pain-relieving properties, while fentanyl is a strong pain reliever that provides sedation.
Study on the Effects of Metoprolol in Patients with Acute Respiratory Distress Syndrome (ARDS)
This Spanish study investigates metoprolol tartrate for patients with the condition. Participants must be between 18 and 79 years old with a clinical diagnosis from any cause such as pneumonia, sepsis, pancreatitis, or trauma, and be admitted to the ICU. They must have had orotracheal intubation and be on mechanical ventilation within 72 hours before selection. Patients must have moderate to severe condition with a PaO2/FiO2 ratio of 200 mmHg or less under specific ventilator settings, a heart rate of at least 60 bpm, and an invasive systolic blood pressure of at least 110 mmHg.
The study compares metoprolol tartrate given intravenously with a placebo. The main goal is to evaluate how many days participants are alive and free from invasive mechanical ventilation during the first 28 days. Secondary outcomes include overall survival rate at 28 days, ventilator-free days, ICU stay duration over three months, and quality of life assessed using the SF-36 questionnaire.
Metoprolol is a beta-blocker that works by blocking certain receptors in the heart and blood vessels, helping to lower heart rate and blood pressure. This potentially reduces stress on the heart and lungs, which may help improve lung function and breathing in patients with the condition.
Additional trials are available beyond the ten described above. These studies continue to explore various treatment approaches for the condition across multiple European countries.
Summary
The 13 ongoing clinical trials for Acute Respiratory Distress Syndrome represent diverse therapeutic approaches being tested across Europe. A significant concentration of trials is taking place in countries such as France, Spain, Italy, and Germany, with several multi-national studies spanning up to ten countries. This geographical distribution reflects both the severity of the condition and the international effort to find effective treatments.
Several trials focus on anti-inflammatory approaches using medications like anakinra, reparixin, and high-dose vitamin C. Others explore novel sedation strategies with inhaled sevoflurane or investigate antifibrotic agents like pirfenidone to prevent lung scarring. Specialized imaging studies are examining disease progression at the cellular level, while cardiovascular medications like metoprolol are being tested for their potential lung-protective effects.
Most trials target adult patients in intensive care settings who require mechanical ventilation, though inclusion criteria vary regarding disease severity and specific inflammatory markers. The primary outcomes typically focus on ventilator-free days and survival rates, reflecting the critical nature of this condition and its impact on patients’ ability to breathe independently.
