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138 active trials for Acute Respiratory Distress Syndrome

Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)

This study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital, Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH), Duke University Hospital, Durham Veterans Administration Medical Center, New York-Presbyterian Brooklyn Methodist Hospital, and Duke Regional Hospital. The purpose of this study is to evaluate the safety, tolerability, and efficacy of inhaled carbon monoxide (iCO) for the treatment of ARDS and to examine the biologic readouts of low dose iCO therapy in patients with ARDS

Start: July 2019

Measurement of Airway Opening Pressure (AOP) in Patients With Acute Respiratory Distress Syndrom and With or Without Covid 19.

Mechanical ventilation in ARDS requires protective ventilation and PEEP. Airway closer has to be overcome to reduce lung heterogeneity, AOP is measured globally with a ventilator PV curve without PEEP. EIT derived PV curve is another method that could determine heterogeneity of AOP between both lung. This study aims to determine whether AOP measured with EIT derived PV curve is similar to AOP on the ventilator PV curve and see if AOP is different between lungs. If airway closer is higher on one lung, global AOP on the ventilator PV curve probably estimates the other lung.

Start: May 2020

A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19

This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.

Start: December 2020

Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19

Start: October 2020

Pilot Clinical Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)

The primary object of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS (ARDS caused by Non-COVID-19 or COVID-19).

Start: May 2021

The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause

This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure

Start: August 2020

Tolerability and Efficacy of RJX in Patients With COVID-19

This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.

Start: March 2021

Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS)

The clinical study with UMC119-06 is designed to investigate the safety in patients with moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. UMC119-06 is ex vivo cultured human umbilical cord derived mensenchymal stem cells (hUC-MSCs) product which is intended for treatment of ARDS.

Start: September 2021

Sevoflurane PharmacokInetics in ARDS

The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung imaging phenotypes (focal vs nonfocal) during ARDS in ICU patients.

Start: February 2020

Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

The main objective of the study is to assess the feasibility, safety, and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.

Start: December 2019

Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved. If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19. However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

Start: October 2020

Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.

Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor. Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS. However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers. There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS. However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details. Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table. The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.

Start: September 2021

A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19

The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.

Start: December 2020

Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.

Start: February 2018

Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection

The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.

Start: May 2020

Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure

Mechanical ventilation can cause damage by overstretching the lungs, especially when the lungs are collapsed or edematous. Raising ventilator pressures can reduce lung collapse and this can prevent overstretching from mechanical ventilation. It remains uncertain how much pressure (PEEP - positive end-expiratory pressure) should be used on the ventilator and how to identify patients who will benefit from higher ventilator pressures vs. lower ventilator pressures. The investigators are using a unique new imaging technology, electrical impedance tomography (EIT), to study this problem and to determine the safest and most effective ventilator pressure level. The results of this study will inform future trials of higher vs. lower PEEP strategies in mechanically ventilated patients.

Start: March 2019

Safety Study of Inhaled Carbon Monoxide to Treat Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)

This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a target carboxyhemoglobin (COHb) level of 6-8% in patients with sepsis-induced ARDS. We will also examine the biologic readouts of low dose iCO therapy in patients with sepsis-induced ARDS.

Start: September 2022

Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial

This is a Phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in patients with COVID-19 and Acute Respiratory Distress Syndrome (ARDS). Randomized participants (N=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs) or blinded placebo. The MSC product will be provided as 2.5 million cells/ml suspended in PlasmaLyte A containing 5% Human Albumin. The appearance-matched placebo product contains the same excipients, PlasmaLyte A and 5% Human Albumin, as the UC-MSCs.

Start: April 2021

Explore Potential Plasma Biomarkers of Acute Respiratory Distress Syndrome (ARDS) Using Proteomics Analysis in Patients Undergoing Cardiopulmonary Bypass

The investigators aimed to establish a prospective cohort of patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to September 2022, in Wuhan. The ARDS events, ventilation time, time of extubation, oxygenation index for 3 days after operation, length of ICU stay and postoperative death events were observed. Plasma samples were collected before CPB, and several time points after CPB. Dynamic differential proteins of ARDS after CPB were screened by DIA (Data independent acquisition) proteomics. Quantitative protein marker concentration was used to predict the occurrence of ARDS after operation, the model discrimination and calibration was assessed.

Start: April 2021

Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.

Start: May 2020