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Acute Lung Injury clinical trials

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NCT ID: NCT05365321 Not yet recruiting - COVID-19 Clinical Trials

Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19

WP1122
Start date: December 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1, multi-center, dose escalation study that is followed by a Phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of WP1122 administered q12h ±1 hr PO in adult patients with COVID-19 who require hospitalization with respiratory support. The Phase 1 component will enroll COVID-19 positive patients who are symptomatic and the Phase 2 component will enroll adults with COVID-19 who require hospitalization for respiratory support and those patients requiring intubation with mechanical ventilation.

NCT ID: NCT05343338 Not yet recruiting - Aortic Dissection Clinical Trials

Improvement of Pulmonary Insufficiency After Aortic Dissection With Sivelestat Sodium

IPIADSS
Start date: April 20, 2022
Phase: N/A
Study type: Interventional

Aortic dissection (AD) is one of the most dangerous cardiovascular emergencies, with rapid onset, rapid progression, high fatality rate, and a variety of life-threatening complications. Acute lung injury (ALI) caused by AD is an important cause of many adverse outcomes. Studies have confirmed that 34.9% to 53.8% of AAD patients have ALI before surgery, and Impaired preoperative lung function may lead to worse oxygenation after AD surgery. The pathophysiological mechanism of AD-induced ALI is complex. A variety of preoperative and intraoperative risk factors can induce or aggravate ALI, such as ischemia-reperfusion injury, deep hypothermic circulatory arrest, and inflammatory reactions. At present, the clinical use of improved surgery, cardiopulmonary bypass perfusion, early anti-inflammatory treatment, and protective lung ventilation can reduce and improve perioperative ALI to a certain extent, but it is still not ideal. In recent years, inhibition of neutrophil activation and aggregation, and reduction of neutrophil elastase activity as targets for the treatment of inflammatory injury have also become an important clinical treatment measure, in order to further reduce the body's inflammatory response to improve and alleviate ALI. Sivelestat sodium, as a neutrophil elastase inhibitor, is the only approved therapeutic drug for ALI/ acute respiratory distress syndrome (ARDS) in the world. It is precisely by reducing the inflammatory infiltration of neutrophils and inhibiting neutrophil elastase activity, thereby exerting a certain protective effect on the lungs. The study takes patients with AD surgery as the research object. On the basis of not terminating and changing the original treatment plans, sivelestat sodium was added in the perioperative period to observe the incidence, and severity of ALI/ARDS in the perioperative period. It aims to explore the efficacy and safety of sivelestat sodium in the treatment of pulmonary insufficiency after AD arch surgery under hypothermic circulatory arrest.

NCT ID: NCT05258682 Not yet recruiting - COVID-19 Clinical Trials

Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease

Start date: May 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

COVID-19 has multiple facets including cytokine storm, thromboembolism and gelatinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious, in which patients succumb to acute respiratory distress syndrome (ARDS). In other severe respiratory disease such as ventilator associated pneumonia (VAP), formation of biofilm in the endotracheal tube causes infection to spread to the lungs, resulting in respiratory decline and high mortality. The development of gelatinous sputum plugs correlates with negative outcome. Both groups of patients still have limited therapy options. BromAc is a potent mucolytic, biofilm degrader, cleaves the glycoproteins of the SARS-CoV-2 virus (antiviral), and down regulates cytokines and chemokine in COVID-19 sputum. The investigators seek to examine the safety and attempt to gain preliminary efficacy of nebulised BromAc in moderate to severe COVID-19 and other mucus producing, severe, respiratory diseases.

NCT ID: NCT05241067 Not yet recruiting - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in COVID-19 Patients With ARDS

Start date: March 31, 2024
Phase: Phase 2
Study type: Interventional

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus causing coronavirus disease 2019 (COVID-19), which has been a global pandemic since March 2020. According to WHO, more than 289 million cases have been confirmed worldwide, with just over 5.4 million reported deaths as of January 2022. SARS-CoV-2 variants continue to emerge, with the omicron variant causing the increased surge in cases. Currently, Johns Hopkins University of Medicine reports a case fatality rate of 1.5% for the United States. COVID-19 infections may be asymptomatic in some cases, while most cases cause mild to moderate illness with respiratory and flu-like symptoms. However, a significant number of COVID-19 cases develop severe life-threatening illness involving severe pneumonia and acute respiratory distress syndrome (ARDS), requiring admission to the intensive care unit (ICU) Although there have been breakthroughs in the treatment for COVID-19, most of these are directed at mild-to-moderate disease rather than patients with severe disease on mechanical ventilators. There is still a need for novel and effective treatment options in severe COVID-19 illness with continued vaccine hesitancy, decreased social distancing, and new emerging variants. Centhaquine is a first-in-class resuscitative agent for the hypovolemic shock that is approved for marketing in India. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647). Clinical phase II (CTRI/2017/03/008184) and phase III (CTRI/2019/01/017196) results indicate that centhaquine is a novel first-in-class, highly effective resuscitative agent for hypovolemic shock. Centhaquine provided hemodynamic stability and significantly improved acute respiratory distress syndrome (ARDS) and multiple organ dysfunction score (MODS) in clinical trials conducted in India. A total of 155 patients with hypovolemic shock have been studied (combined phase II and III). Centhaquine is safe and reduced the mortality from 10.71% in patients receiving standard treatment to 2.20% in patients that received centhaquine (odds ratio 5.340; 95% CI 1.270-26.50; P=0.0271). In a phase 3 study of hypovolemic shock, ARDS and MODS were secondary endpoints, and centhaquine reduced both with a significant p-value.

NCT ID: NCT05225194 Not yet recruiting - COVID-19 Clinical Trials

Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil

Start date: February 15, 2022
Phase:
Study type: Observational

The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS). This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.

NCT ID: NCT05212662 Not yet recruiting - COVID-19 Clinical Trials

Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This is multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics (PD) and efficacy of TTI-0102 for the treatment of patients with mild to moderate COVID-19. This is a phase 2 study of cysteamine-pantetheine disulfide (TTI-0102), an antiviral, anti-infectious, antioxidant and anti-CRS (cytokine release syndrome) investigational drug. Subjects will be randomized 2:1 to receive TTI-0102 or placebo daily for up to 14 days. Up to 5 centers in the US and Canada will conduct this study. 60 patients will be enrolled.

NCT ID: NCT05198986 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

Start date: February 1, 2022
Phase:
Study type: Observational

The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications. In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.

NCT ID: NCT05178199 Not yet recruiting - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

The Effectiveness of RPSG Intervention for Nurses During the COVID-19

Start date: January 2022
Phase: N/A
Study type: Interventional

The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The study supposes "RPSG" could improve nurses' self-efficacy, fear of COVID-19, psychological distress, and quality of life.

NCT ID: NCT05092724 Not yet recruiting - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study.

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

In December 2019, a sudden public health incident (the corona virus disease [COVID-19] epidemic) occurred in Wuhan, China. Clinical features of those with pneumonia include fever and cough, and in many cases a sudden and accelerating respiratory distress originated from interstitial pneumonia . Many hypotheses have explained hypoxemia in COVID-19 patients, such as hyperimmune reaction to viral infection and cytokine storm that leads to serious lung tissue and alveolar damage or even direct viral insult . Mortality are as high as 15% in critically ill patients requiring intensive care unit admission and oxygen therapy , suggesting an urgent need to try therapeutic interventions in addition to supportive treatment. There is more than one type of hemoglobin. In adults, Hb A or Adult hemoglobin which is the main hemoglobin in the blood. But there is another type of hemoglobin called fetal hemoglobin. Fetal hemoglobin (hemoglobin F, Hb F, or α2γ2) is the main oxygen carrier protein in the human fetus. and the levels remain high after birth until the baby is roughly 2-4 months old . Hemoglobin F has a different composition from hemoglobin A and higher affinity to oxygen . At birth, hemoglobin F accounts for 50-95% of the infant's hemoglobin and at around 6 months after birth, hemoglobin A becomes the predominant type.The key feature that allows hemoglobin F to bind more strongly to oxygen is by having γ subunits (instead of β, in Hb A for example). 2,3-BPG interacts much more with hemoglobin A than hemoglobin F . A hypothesis for the low incidence of the COVID-19 infection in pediatric is the presence of fetal hemoglobin (HbF) . In a preliminary study about the prevalence of hemoglobinopathies in different countries and the mortality rate of COVID-19, it appears that the mortality is lower in countries with a higher prevalence of hemoglobinopathies . Mice treated with GBT1118 (a compound that enhances the oxygen affinity of hemoglobin) showed a sustained significant increase in SpO2 over 4 h of hypoxia exposure. People with haemoglobinopathies like sickle cell anemia or beta-thalassemia attributed with high amount of fetal hemoglobin, become mostly asymptomatic or have mild symptoms . The volume of umbilical cord blood varies from 50 ml to 140 ml with a mean of 85 ml rich in fetal hemoglobin . Mesenchymal stem cells (MSCs) have been widely used in the clinical setting, not only for autoimmune diseases but also for infectious diseases , and their safety and effectiveness have been well elucidated . As a noninvasive treatment, hUC-MSC therapy is a very effective and promising method for clinical application and promotion to treat severe COVID-19 the investigators offer a solution by increasing fetal hemoglobin by cord blood containing fetal blood transfusion in the critical patients as a trial to combat the course of the disease and minimize the morbidity especially in sever cases who suffer from desaturation until suppression of the immune dysregulation and avoidance of the impending death.

NCT ID: NCT05031858 Not yet recruiting - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Effect of Vojta Therapy on Covid-19 Respiratory Disease

Start date: September 25, 2021
Phase: N/A
Study type: Interventional

Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.