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Acute Lung Injury clinical trials

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NCT ID: NCT04524156 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2

COVID-pO2-RAAS
Start date: October 4, 2020
Phase: N/A
Study type: Interventional

The first case of a person infected with SARS-Cov-2 virus can be tracked back on November the 17th, 2019, in China. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 outbreak a pandemic. On April 13, COVID-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. The real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested. The percentage of patients with COVID-19 needed for intensive care unit (ICU) varied from 5 to 32% in Wuhan, China. It was up to 9% in Lombardy, Italy. According to available data from Lombardy, 99% of patients admitted to the ICU needed respiratory support (88% invasive ventilation, 11% non invasive ventilation). The aim of the present investigation is to test the hypothesis whether transcutaneous partial O2 and CO2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ARDS) development in hospitalized clinically stable COVID-19 positive patients and to clarify the role of the Angiotensin Converting Enzyme 2 (ACE2) and its final product, angiotensin 2 (Ang II) in the pathogenesis of this systemic disease. We also aim to test the hypothesis that plasma concentration of Clara Cell protein (CC16) and surfactant protein D (SPD), which are a biomarkers of acute lung injury, are severely decreased in COVID-19 positive patients and the plasma concentration is related to the severity of lung injury.

NCT ID: NCT04507802 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Start date: August 2020
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)

NCT ID: NCT04452097 Not yet recruiting - COVID-19 Clinical Trials

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS

Start date: July 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.

NCT ID: NCT04412395 Not yet recruiting - COVID-19 Clinical Trials

Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease

COVID-19_LF
Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

NCT ID: NCT04395456 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19)

A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)

SAVE
Start date: September 2021
Phase: Phase 2
Study type: Interventional

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection. We will assess the efficacy and safety, as well as pharmacokinetics (PK), and pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.

NCT ID: NCT04358627 Not yet recruiting - Inflammation Clinical Trials

Dexmedetomidine to Improve Outcomes of ARDS in Critical Care COVID-19 Patients

COVID-DEX
Start date: April 15, 2020
Phase:
Study type: Observational

A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series

NCT ID: NCT04347967 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

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

Start date: January 1, 2024
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT04317469 Not yet recruiting - ARDS, Human Clinical Trials

Evaluation of Von Willebrand Factor as a Marker For Early Diagnosis of Acute Respiratory Distress Syndrome (A.R.D.S) in Comparison to Interleukin 6 [IL-6]

Start date: March 21, 2020
Phase:
Study type: Observational

In this prospective study of 60patients, we tested the hypothesis That markedly elevated levels of plasma von Willebrand factor (VWF) a marker of endothelial cell injury might predict the development of acute respiratory distress syndrome (A.R.D.S) in risky patients. We compared our result to IL.6 as control biomarker for A.R.D.S development. Acute lung injury was quantified on two -point scoring system (Berlin definition of ARDS and Murray score of acute lung injury). Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).

NCT ID: NCT04286490 Not yet recruiting - Acute Kidney Injury Clinical Trials

Prone Position and Renal Resistive Index

PRO-KIDNEY
Start date: June 2020
Phase: N/A
Study type: Interventional

Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of radiological and biological kidney injury markers, intra-abdominal pressure (IAP) and ventilatory mechanics in supine position (baseline IAP), after 2 hours in PP at the current IAP value, thirty minutes after patients' abdomen suspension in order to resume baseline IAP and after patients' are turned back to supine position.

NCT ID: NCT04208126 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)

ELIEO
Start date: April 2022
Phase: N/A
Study type: Interventional

This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for Acute Respiratory Distress Syndrome (ARDS) with an Extracorporal Membrane Oxygenation (ECMO) immediately after admission to the intensive care unit or conservative treatment. The later can undergo ECMO following failure of conservative therapy as a rescue therapy. Patients will be included within 96h of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until hospital discharge.